HydrocephalusNCT07679035
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
A study testing Rhaeos Shunt Monitoring System (RSMS) and ShuntCheck III in people with Hydrocephalus, run by Rhaeos, Inc. at 1 site in United States.
Trial summary
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Rhaeos Shunt Monitoring System (RSMS) and ShuntCheck III
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Existing ventricular cerebrospinal fluid (CSF) shunt. Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device.
- Written informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations.
- For participants with planned "virtual off" measurements:
- Existing ventricular CSF shunt with a programmable valve that has an available manufacturer-reported "virtual off" setting and can be programmed noninvasively.
- For participants whose valve will be adjusted to the "virtual off" setting during the study:
- Subject-reported or documented history of successful shunt valve adjustment(s).
Who cannot join
- Presence of more than one distal shunt catheter in the study device measurement region.
- Presence of an open wound or edema in the study device measurement region that would interfere with device placement.
- Shunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound.
- Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives.
- New or worsening symptoms suggestive of shunt malfunction within the previous 7 days.
- Use of the study device would interfere with standard patient care, emergency surgery cannot be delayed, or study participation would interfere with optimal medical care.
Show all 11Show fewer
- Participation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study.
- Previous participation in a Rhaeos clinical study using the current-generation RH05-B1 study device.
- For participants with planned "valve normal" measurements only:
- Investigator judges the participant is likely to be shunt independent (e.g., does not require a functional shunt for management of hydrocephalus).
- This format follows ClinicalTrials.gov conventions by separating general criteria from those that apply only to specific participant subgroups.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rhaeos, Imc
Chicago, Illinois, 60642
Anna L Somera, 855-814-3569, info@rhaeos.com
About this study
Official title: A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow-Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients.
The purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt.
Read more
Approximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided "virtual off" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting.
During the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded.
The primary goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts with flow-permissive ("valve normal") and restricted-flow ("virtual off") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.
Read the detailed description
Hydrocephalus is commonly treated with surgically implanted cerebrospinal fluid (CSF) shunts that divert excess CSF from the brain to another part of the body. Shunt malfunction is a frequent complication of treatment and can result in significant morbidity if not identified and treated promptly. However, diagnosis of shunt malfunction remains challenging because patient symptoms are often nonspecific and currently available diagnostic tools have important limitations. Existing noninvasive assessments generally rely on indirect indicators of shunt function, while invasive procedures may expose patients to discomfort, infection risk, or other complications.
The Rhaeos Shunt Monitoring System (RSMS) is an investigational, wireless, noninvasive device designed to aid in the detection of flow in implanted CSF shunts. RSMS uses thermal sensing technology to evaluate CSF flow through shunt tubing by measuring temperature changes associated with fluid movement. The device is placed on the skin overlying a palpable shunt segment, typically near the clavicle, and communicates wirelessly with a tablet application to perform measurements and record results.
This study is a prospective, multicenter, open-label, blinded, observational study designed to compare the performance of RSMS with ShuntCheck III, an FDA-cleared noninvasive device indicated as an aid to the detection of flow in implanted CSF shunts. Both devices use transcutaneous thermal sensing methods to assess shunt flow, but they differ in implementation. RSMS uses a controlled heating element and wireless electronics, while ShuntCheck III uses a disposable thermosensor and cooling from an instant cold pack.
Approximately 85 pediatric and adult participants with existing ventricular CSF shunts will be enrolled. Eligible participants must have a palpable shunt segment suitable for device placement and must not have recent symptoms suggestive of shunt malfunction.
Participants with programmable shunt valves capable of being adjusted to a manufacturer-defined "virtual off" setting (opening pressure greater than 400 mm H₂O) will undergo device assessments after the valve has been adjusted to the virtual off setting. These participants may also undergo optional measurements at their prescribed flow-permissive ("valve normal") setting prior to valve adjustment. Participants whose valves are not adjusted will undergo measurements only at their prescribed valve setting. For each assessment, the order of RSMS and ShuntCheck III testing will be randomized. Participants and treating clinicians will remain blinded to device outputs throughout the study.
The primary objective of the study is to compare the sensitivity and specificity of RSMS and ShuntCheck III for detecting flow-restricted and flow-permissive shunt conditions. Device performance will be evaluated using the known valve setting as the reference condition. Measurements obtained while the valve is set to the virtual off setting will serve as flow-restricted conditions, while measurements obtained at valve-normal settings will serve as flow-permissive conditions.
Secondary analyses will evaluate additional performance characteristics, including accuracy, positive predictive value, negative predictive value, receiver operating characteristic (ROC) curve analysis, measurement completion rates, and the number of measurement attempts required to obtain a successful result. Exploratory analyses will assess device performance across clinical and demographic subgroups and study-specific variables such as body position, shunt depth, valve setting, and study site.
All study procedures are conducted in conjunction with standard clinical care. Device measurements are used solely for research purposes and will not be available to treating clinicians for patient management decisions. Participants undergoing temporary valve adjustment will be monitored following restoration of their prescribed valve setting, and all participants will be monitored for adverse events associated with device use. Adverse events, device deficiencies, and protocol deviations will be documented throughout the study.
The results of this study are intended to provide clinical evidence regarding the performance of a next-generation, wireless, noninvasive shunt flow monitoring technology and to support future regulatory evaluation of the RSMS device.
- Conditions
- Hydrocephalus
- Being tested
- Rhaeos Shunt Monitoring System (RSMS), ShuntCheck III
- Keywords
- shunt, csf, cerebrospinal fluid, rhaeos, VP shunt
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhaeos Shunt Monitoring System (RSMS)Device
The Rhaeos Shunt Monitoring System (RSMS) is an investigational, wireless, noninvasive thermal flow detection device that is applied to the skin overlying an implanted cerebrospinal fluid (CSF) shunt. The device uses controlled thermal energy and temperature sensors to detect thermal patterns associated with CSF flow. Measurements are obtained using a tablet application, and device results are encoded to maintain blinding. The device is used for research purposes only and is not used to guide clinical care.
ShuntCheck IIIDevice
ShuntCheck III is an FDA-cleared, noninvasive thermal flow detection device used as the predicate comparator. The device uses transcutaneous thermal dilution produced by an instant cold pack and a disposable thermosensor array applied over the implanted CSF shunt to detect shunt flow. Measurements are obtained using the manufacturer's software, and results are encoded to maintain blinding. The device is used for comparison with the investigational device and is not used to guide clinical care during the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants Undergoing Paired CSF Shunt Flow Assessment | Other | Participants undergo paired, noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using both the investigational Rhaeos® Shunt Monitoring System (RSMS) and the FDA-cleared predicate device, ShuntCheck III. The order of device use is randomized for each participant. All participants are evaluated at their prescribed flow-permissive ("valve normal") shunt setting. Participants with programmable shunt valves that can be adjusted to a manufacturer-reported "virtual off" setting also undergo measurements after temporary adjustment to the "virtual off" setting, followed by return of the valve to the prescribed setting. Device results are blinded to participants and treating clinicians and are not used for clinical decision-making. Adverse events are monitored throughout study participation. Receives: Device: Rhaeos Shunt Monitoring System (RSMS); Device: ShuntCheck III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck III
Sensitivity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying non-flowing cerebrospinal fluid shunts during the "virtual off" valve setting. Sensitivity is calculated as the proportion of "virtual off" measurements correctly identified as "flow not confirmed."
Measured: Day 1 (study visit)
Specificity of the Rhaeos® Shunt Monitoring System Compared With ShuntCheck III
Specificity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying flow-permissive cerebrospinal fluid shunts during the prescribed "valve normal" setting. Specificity is calculated as the proportion of flow-permissive measurements correctly identified as "flow confirmed."
Measured: Day 1 (study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhaeos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Springfield Clinic, OSF Healthcare System, Johns Hopkins University, SUNY Research Foundation, Northwestern Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679035
- Sponsor's protocol ID
- 2026-01
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Xu J, Poole C, Sahyouni R, Chen J. Noninvasive thermal evaluation for shunt failure in the emergency room. Surg Neurol Int. 2019 Dec 27;10:254. doi: 10.25259/SNI_324_2019. eCollection 2019.
PubMed 31893155Marlin AE, Gaskill SJ. The use of transcutaneous thermal convection analysis to assess shunt function in the pediatric population. Neurosurgery. 2012 Jun;70(2 Suppl Operative):181-3. doi: 10.1227/NEU.0b013e31823cf18d.
PubMed 22009251Kadowaki C, Hara M, Numoto M, Takeuchi K, Saito I. CSF shunt physics: factors influencing inshunt CSF flow. Childs Nerv Syst. 1995 Apr;11(4):203-6. doi: 10.1007/BF00277654.
PubMed 7621480Drake JM, Martin AJ, Henkleman RM. Determination of cerebrospinal fluid shunt obstruction with magnetic resonance phase imaging. J Neurosurg. 1991 Oct;75(4):535-40. doi: 10.3171/jns.1991.75.4.0535.
PubMed 1885970Madsen JR, Abazi GS, Fleming L, Proctor M, Grondin R, Magge S, Casey P, Anor T. Evaluation of the ShuntCheck noninvasive thermal technique for shunt flow detection in hydrocephalic patients. Neurosurgery. 2011 Jan;68(1):198-205; discussion 205. doi: 10.1227/NEU.0b013e3181fe2db6.
PubMed 21099708Madsen JR, Boyle TP, Neuman MI, Park EH, Tamber MS, Hickey RW, Heuer GG, Zorc JJ, Leonard JR, Leonard JC, Keating R, Chamberlain JM, Frim DM, Zakrzewski P, Klinge P, Merck LH, Piatt J, Bennett JE, Sandberg DI, Boop FA, Hameed MQ. Diagnostic Accuracy of Non-Invasive Thermal Evaluation of Ventriculoperitoneal Shunt Flow in Shunt Malfunction: A Prospective, Multi-Site, Operator-Blinded Study. Neurosurgery. 2020 Oct 15;87(5):939-948. doi: 10.1093/neuros/nyaa128.
PubMed 32459841Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Dec 1;97(6):1397-1405. doi: 10.1227/neu.0000000000003569. Epub 2025 Jun 16.
PubMed 40522244Webb RC, Ma Y, Krishnan S, Li Y, Yoon S, Guo X, Feng X, Shi Y, Seidel M, Cho NH, Kurniawan J, Ahad J, Sheth N, Kim J, Taylor JG 6th, Darlington T, Chang K, Huang W, Ayers J, Gruebele A, Pielak RM, Slepian MJ, Huang Y, Gorbach AM, Rogers JA. Epidermal devices for noninvasive, precise, and continuous mapping of macrovascular and microvascular blood flow. Sci Adv. 2015 Oct 30;1(9):e1500701. doi: 10.1126/sciadv.1500701. eCollection 2015 Oct.
PubMed 26601309Krishnan SR, Ray TR, Ayer AB, Ma Y, Gutruf P, Lee K, Lee JY, Wei C, Feng X, Ng B, Abecassis ZA, Murthy N, Stankiewicz I, Freudman J, Stillman J, Kim N, Young G, Goudeseune C, Ciraldo J, Tate M, Huang Y, Potts M, Rogers JA. Epidermal electronics for noninvasive, wireless, quantitative assessment of ventricular shunt function in patients with hydrocephalus. Sci Transl Med. 2018 Oct 31;10(465):eaat8437. doi: 10.1126/scitranslmed.aat8437.
PubMed 30381410Luciano M, Holubkov R, Williams MA, Malm J, Nagel S, Moghekar A, Eklund A, Zwimpfer T, Katzen H, Hanley DF, Hamilton MG; PENS Co-investigators and AHCRN Site PIs. Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial. Neurosurgery. 2023 Mar 1;92(3):481-489. doi: 10.1227/neu.0000000000002225. Epub 2022 Nov 25.
PubMed 36700738Holmgren RT, Nilsson M, Georgiopoulos C, Zsigmond P. A Randomized Double-Blinded Clinical Study of Early Volumetric Changes After Shunt Surgery and MRI-Resistance of the Codman Certas(R) Plus Shunt Valve. World Neurosurg. 2025 Oct;202:124424. doi: 10.1016/j.wneu.2025.124424. Epub 2025 Aug 29.
PubMed 40887008Krishnan SR, Arafa HM, Kwon K, Deng Y, Su CJ, Reeder JT, Freudman J, Stankiewicz I, Chen HM, Loza R, Mims M, Mims M, Lee K, Abecassis Z, Banks A, Ostojich D, Patel M, Wang H, Borekci K, Rosenow J, Tate M, Huang Y, Alden T, Potts MB, Ayer AB, Rogers JA. Continuous, noninvasive wireless monitoring of flow of cerebrospinal fluid through shunts in patients with hydrocephalus. NPJ Digit Med. 2020 Mar 6;3:29. doi: 10.1038/s41746-020-0239-1. eCollection 2020.
PubMed 32195364
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow-Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor
- ClinicalTrials.gov ID
- NCT07679035
- Acronym / sponsor ID
- 2026-01
- Conditions
- Hydrocephalus
- Keywords
- shunt, csf, cerebrospinal fluid, rhaeos, VP shunt
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Springfield Clinic, OSF Healthcare System, Johns Hopkins University, SUNY Research Foundation, Northwestern Memorial Hospital
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients.
The purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt.
Approximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided "virtual off" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting.
During the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded.
The primary goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts with flow-permissive ("valve normal") and restricted-flow ("virtual off") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.
Detailed description
Hydrocephalus is commonly treated with surgically implanted cerebrospinal fluid (CSF) shunts that divert excess CSF from the brain to another part of the body. Shunt malfunction is a frequent complication of treatment and can result in significant morbidity if not identified and treated promptly. However, diagnosis of shunt malfunction remains challenging because patient symptoms are often nonspecific and currently available diagnostic tools have important limitations. Existing noninvasive assessments generally rely on indirect indicators of shunt function, while invasive procedures may expose patients to discomfort, infection risk, or other complications.
The Rhaeos Shunt Monitoring System (RSMS) is an investigational, wireless, noninvasive device designed to aid in the detection of flow in implanted CSF shunts. RSMS uses thermal sensing technology to evaluate CSF flow through shunt tubing by measuring temperature changes associated with fluid movement. The device is placed on the skin overlying a palpable shunt segment, typically near the clavicle, and communicates wirelessly with a tablet application to perform measurements and record results.
This study is a prospective, multicenter, open-label, blinded, observational study designed to compare the performance of RSMS with ShuntCheck III, an FDA-cleared noninvasive device indicated as an aid to the detection of flow in implanted CSF shunts. Both devices use transcutaneous thermal sensing methods to assess shunt flow, but they differ in implementation. RSMS uses a controlled heating element and wireless electronics, while ShuntCheck III uses a disposable thermosensor and cooling from an instant cold pack.
Approximately 85 pediatric and adult participants with existing ventricular CSF shunts will be enrolled. Eligible participants must have a palpable shunt segment suitable for device placement and must not have recent symptoms suggestive of shunt malfunction.
Participants with programmable shunt valves capable of being adjusted to a manufacturer-defined "virtual off" setting (opening pressure greater than 400 mm H₂O) will undergo device assessments after the valve has been adjusted to the virtual off setting. These participants may also undergo optional measurements at their prescribed flow-permissive ("valve normal") setting prior to valve adjustment. Participants whose valves are not adjusted will undergo measurements only at their prescribed valve setting. For each assessment, the order of RSMS and ShuntCheck III testing will be randomized. Participants and treating clinicians will remain blinded to device outputs throughout the study.
The primary objective of the study is to compare the sensitivity and specificity of RSMS and ShuntCheck III for detecting flow-restricted and flow-permissive shunt conditions. Device performance will be evaluated using the known valve setting as the reference condition. Measurements obtained while the valve is set to the virtual off setting will serve as flow-restricted conditions, while measurements obtained at valve-normal settings will serve as flow-permissive conditions.
Secondary analyses will evaluate additional performance characteristics, including accuracy, positive predictive value, negative predictive value, receiver operating characteristic (ROC) curve analysis, measurement completion rates, and the number of measurement attempts required to obtain a successful result. Exploratory analyses will assess device performance across clinical and demographic subgroups and study-specific variables such as body position, shunt depth, valve setting, and study site.
All study procedures are conducted in conjunction with standard clinical care. Device measurements are used solely for research purposes and will not be available to treating clinicians for patient management decisions. Participants undergoing temporary valve adjustment will be monitored following restoration of their prescribed valve setting, and all participants will be monitored for adverse events associated with device use. Adverse events, device deficiencies, and protocol deviations will be documented throughout the study.
The results of this study are intended to provide clinical evidence regarding the performance of a next-generation, wireless, noninvasive shunt flow monitoring technology and to support future regulatory evaluation of the RSMS device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Undergoing Paired CSF Shunt Flow Assessment | Other | Device: Rhaeos Shunt Monitoring System (RSMS), Device: ShuntCheck IIIParticipants undergo paired, noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using both the investigational Rhaeos® Shunt Monitoring System (RSMS) and the FDA-cleared predicate device, ShuntCheck III. The order of device use is randomized for each participant. All participants are evaluated at their prescribed flow-permissive ("valve normal") shunt setting. Participants with programmable shunt valves that can be adjusted to a manufacturer-reported "virtual off" setting also undergo measurements after temporary adjustment to the "virtual off" setting, followed by return of the valve to the prescribed setting. Device results are blinded to participants and treating clinicians and are not used for clinical decision-making. Adverse events are monitored throughout study participation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Existing ventricular cerebrospinal fluid (CSF) shunt. Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device.
- Written informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations.
- Existing ventricular CSF shunt with a programmable valve that has an available manufacturer-reported "virtual off" setting and can be programmed noninvasively.
- For participants whose valve will be adjusted to the "virtual off" setting during the study:
- Subject-reported or documented history of successful shunt valve adjustment(s).
Key exclusion criteria (11 listed)
- Presence of more than one distal shunt catheter in the study device measurement region.
- Presence of an open wound or edema in the study device measurement region that would interfere with device placement.
- Shunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound.
- Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives.
- New or worsening symptoms suggestive of shunt malfunction within the previous 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhaeos Shunt Monitoring System (RSMS)The Rhaeos Shunt Monitoring System (RSMS) is an investigational, wireless, noninvasive thermal flow detection device that is applied to the skin overlying an implanted cerebrospinal fluid (CSF) shunt. The device uses controlled thermal energy and temperature sensors to detect thermal patterns associated with CSF flow. Measurements are obtained using a tablet application, and device results are encoded to maintain blinding. The device is used for research purposes only and is not used to guide clinical care. | Device | Participants Undergoing Paired CSF Shunt Flow Assessment |
| ShuntCheck IIIShuntCheck III is an FDA-cleared, noninvasive thermal flow detection device used as the predicate comparator. The device uses transcutaneous thermal dilution produced by an instant cold pack and a disposable thermosensor array applied over the implanted CSF shunt to detect shunt flow. Measurements are obtained using the manufacturer's software, and results are encoded to maintain blinding. The device is used for comparison with the investigational device and is not used to guide clinical care during the study. | Device | Participants Undergoing Paired CSF Shunt Flow Assessment |
Primary outcome
Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck III
Time frame: Day 1 (study visit)
Sensitivity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying non-flowing cerebrospinal fluid shunts during the "virtual off" valve setting. Sensitivity is calculated as the proportion of "virtual off" measurements correctly identified as "flow not confirmed."
Specificity of the Rhaeos® Shunt Monitoring System Compared With ShuntCheck III
Time frame: Day 1 (study visit)
Specificity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying flow-permissive cerebrospinal fluid shunts during the prescribed "valve normal" setting. Specificity is calculated as the proportion of flow-permissive measurements correctly identified as "flow confirmed."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 31893155Xu J, Poole C, Sahyouni R, Chen J. Noninvasive thermal evaluation for shunt failure in the emergency room. Surg Neurol Int. 2019 Dec 27;10:254. doi: 10.25259/SNI_324_2019. eCollection 2019.
- Background: PubMed 22009251Marlin AE, Gaskill SJ. The use of transcutaneous thermal convection analysis to assess shunt function in the pediatric population. Neurosurgery. 2012 Jun;70(2 Suppl Operative):181-3. doi: 10.1227/NEU.0b013e31823cf18d.
- Background: PubMed 7621480Kadowaki C, Hara M, Numoto M, Takeuchi K, Saito I. CSF shunt physics: factors influencing inshunt CSF flow. Childs Nerv Syst. 1995 Apr;11(4):203-6. doi: 10.1007/BF00277654.
- Background: PubMed 1885970Drake JM, Martin AJ, Henkleman RM. Determination of cerebrospinal fluid shunt obstruction with magnetic resonance phase imaging. J Neurosurg. 1991 Oct;75(4):535-40. doi: 10.3171/jns.1991.75.4.0535.
- Background: PubMed 21099708Madsen JR, Abazi GS, Fleming L, Proctor M, Grondin R, Magge S, Casey P, Anor T. Evaluation of the ShuntCheck noninvasive thermal technique for shunt flow detection in hydrocephalic patients. Neurosurgery. 2011 Jan;68(1):198-205; discussion 205. doi: 10.1227/NEU.0b013e3181fe2db6.
- Background: PubMed 32459841Madsen JR, Boyle TP, Neuman MI, Park EH, Tamber MS, Hickey RW, Heuer GG, Zorc JJ, Leonard JR, Leonard JC, Keating R, Chamberlain JM, Frim DM, Zakrzewski P, Klinge P, Merck LH, Piatt J, Bennett JE, Sandberg DI, Boop FA, Hameed MQ. Diagnostic Accuracy of Non-Invasive Thermal Evaluation of Ventriculoperitoneal Shunt Flow in Shunt Malfunction: A Prospective, Multi-Site, Operator-Blinded Study. Neurosurgery. 2020 Oct 15;87(5):939-948. doi: 10.1093/neuros/nyaa128.
- Background: PubMed 40522244Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Dec 1;97(6):1397-1405. doi: 10.1227/neu.0000000000003569. Epub 2025 Jun 16.
- Background: PubMed 26601309Webb RC, Ma Y, Krishnan S, Li Y, Yoon S, Guo X, Feng X, Shi Y, Seidel M, Cho NH, Kurniawan J, Ahad J, Sheth N, Kim J, Taylor JG 6th, Darlington T, Chang K, Huang W, Ayers J, Gruebele A, Pielak RM, Slepian MJ, Huang Y, Gorbach AM, Rogers JA. Epidermal devices for noninvasive, precise, and continuous mapping of macrovascular and microvascular blood flow. Sci Adv. 2015 Oct 30;1(9):e1500701. doi: 10.1126/sciadv.1500701. eCollection 2015 Oct.
- Background: PubMed 30381410Krishnan SR, Ray TR, Ayer AB, Ma Y, Gutruf P, Lee K, Lee JY, Wei C, Feng X, Ng B, Abecassis ZA, Murthy N, Stankiewicz I, Freudman J, Stillman J, Kim N, Young G, Goudeseune C, Ciraldo J, Tate M, Huang Y, Potts M, Rogers JA. Epidermal electronics for noninvasive, wireless, quantitative assessment of ventricular shunt function in patients with hydrocephalus. Sci Transl Med. 2018 Oct 31;10(465):eaat8437. doi: 10.1126/scitranslmed.aat8437.
- Background: PubMed 36700738Luciano M, Holubkov R, Williams MA, Malm J, Nagel S, Moghekar A, Eklund A, Zwimpfer T, Katzen H, Hanley DF, Hamilton MG; PENS Co-investigators and AHCRN Site PIs. Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial. Neurosurgery. 2023 Mar 1;92(3):481-489. doi: 10.1227/neu.0000000000002225. Epub 2022 Nov 25.
- Background: PubMed 40887008Holmgren RT, Nilsson M, Georgiopoulos C, Zsigmond P. A Randomized Double-Blinded Clinical Study of Early Volumetric Changes After Shunt Surgery and MRI-Resistance of the Codman Certas(R) Plus Shunt Valve. World Neurosurg. 2025 Oct;202:124424. doi: 10.1016/j.wneu.2025.124424. Epub 2025 Aug 29.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhaeos Shunt Monitoring System (RSMS) and ShuntCheck III in people with Hydrocephalus, run by Rhaeos, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna L Somera (855-814-3569, info@rhaeos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck III (time frame: Day 1 (study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07679035, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.