Epidural PlacementNCT05616299
BrightPoint Reflectometer Device Study
A study testing BrightPoint in people with Epidural Placement, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Participants are being asked to participate in this study because they are having an epidural placed for labor. This human clinical trial has been designed to evaluate the use of the BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss of Residence (LOR) for lumbar epidural… Read more about this study
- Who is it for?
- Ages 18 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Placement
- What is being tested?
- BrightPoint
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2023to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing an epidural procedure
Who cannot join
- Previous lumbar spine surgery
- Any known spinal abnormality that would interferre with successfully advancing a needle into the epidural space
- Any subject that requires an epidural needle longer than 4.0 inches
- Any procedure requiring use of CSE needles
- Any contraindication to neuraxial anesthesia
- No subjects in advanced active labor, e.g., 6-8 cm dilated
- Tattoo at the site of epidural insertion
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
Participants are being asked to participate in this study because they are having an epidural placed for labor. This human clinical trial has been designed to evaluate the use of the BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss of Residence (LOR) for lumbar epidural placement by an experienced clinician. For this study, participants will be randomized to receive an epidural by an experienced clinician either with or without the use of the BrightPoint device. Epidurals performed as a part of this study will be done in a manner similar to how epidurals are currently performed in the hospital. The epidural space will be entered using usual loss of resistance technique for all patients. If the BrightPoint device is used, it will be as secondary verification of entry into the epidural space.
- Conditions
- Epidural Placement
- Being tested
- BrightPoint
- Keywords
- Labor, Epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightPointDevice
Data from the BrightPoint device during epidural placement will be collected in real time on a tablet with pre-programmed software including tissue color and light reflectance with time stamps of when epidural space is entered as voiced by clinician per LOR.
| Study group | Role | What they receive |
|---|---|---|
| BrightPoint Epidural | Experimental | Subjects will receive an epidural using the BrightPoint device concurrent with usual LOR technique using the same epidural needle, sterile saline, syringe, etc. Receives: Device: BrightPoint |
| Normal Epidural | No intervention | Subjects will have an epidural placed in usual manner with LOR technique using the same epidural needle, sterile saline, syringe etc. but without use of the BrightPoint device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.
This is measured as a Yes or No response.
Measured: Up to 90 minutes
Secondary outcomes (16)
Number of times epidural accessed while using BrightPoint device as measured by clinical log
Measured: Up to 90 minutes
Number of times epidural catheter was used during the procedure as measured by clinical log
Measured: Up to 20 minutes
Number of adverse events as measured by clinician log
Measured: Up to 90 minutes
Number of times the BrightPoint device provided real-time secondary confirmation of Loss of Residence (LOR) as measured by clinician log
Measured: Up to 90 minutes
Number of times the BrightPoint device provided beneficial qualitative/quantitative clinical information to help complete the epidural as measured by clinician log.
Measured: Up to 90 minutes
Number of times clinician experienced the haptic feel of entering the ligamentum flavum (LF) as measured by clinician log
Measured: Up to 90 minutes
Number of times clinician experienced LOR after entering the epidural space as measured by clinician log
Measured: Up to 90 minutes
Number of times clinician experienced the haptic sensation of the needle contacting any tissue that was not expected as measured by clinician log
Measured: Up to 90 minutes
Number of times there were issues with catheterization as measured by clinician log
Measured: Up to 90 minutes
Number of times there were issues achieving pain management as measured by clinician log
Measured: Up to 4 hours
Number of times the device indicated the needle tip was entering the LF as measured by clinician log
Measured: Up to 20 minutes
Number of times the device showed a significant change of color from the light in LF to the dark in ES as measured by clinician log
Measured: Up to 90 minutes
Number of times the device showed a significant change of reflectance from high in LF to low in ES as measured by clinician log
Measured: Up to 90 minutes
Number of times the LOR and BrightPoint device agreed as measured by clinician log
Measured: Up to 90 minutes
Number of times coring was observed during procedure as measured by clinician log
Measured: Up to 90 minutes
Number of times the BrightPoint interfered with the ability to perform the epidural placement in the usual manner with LOR and haptic feedback as measured by clinician log
Measured: Up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start28 Apr 2023
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural PlacementStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lumoptik, Inc.
- Responsible party
- Sponsor
- Investigators
- Lora Levin, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616299
- Sponsor's protocol ID
- STUDY20220677
- Status last verified
- Aug 2023
- First submitted
- 7 Nov 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
- ClinicalTrials.gov ID
- NCT05616299
- Acronym / sponsor ID
- STUDY20220677
- Conditions
- Epidural Placement
- Keywords
- Labor, Epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Lumoptik, Inc.
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 15 Nov 2022 (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.
Participants are being asked to participate in this study because they are having an epidural placed for labor. This human clinical trial has been designed to evaluate the use of the BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss of Residence (LOR) for lumbar epidural placement by an experienced clinician. For this study, participants will be randomized to receive an epidural by an experienced clinician either with or without the use of the BrightPoint device. Epidurals performed as a part of this study will be done in a manner similar to how epidurals are currently performed in the hospital. The epidural space will be entered using usual loss of resistance technique for all patients. If the BrightPoint device is used, it will be as secondary verification of entry into the epidural space.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrightPoint Epidural | Experimental | Device: BrightPointSubjects will receive an epidural using the BrightPoint device concurrent with usual LOR technique using the same epidural needle, sterile saline, syringe, etc. |
| Normal Epidural | No intervention | –Subjects will have an epidural placed in usual manner with LOR technique using the same epidural needle, sterile saline, syringe etc. but without use of the BrightPoint device. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing an epidural procedure
Key exclusion criteria (7 listed)
- Previous lumbar spine surgery
- Any known spinal abnormality that would interferre with successfully advancing a needle into the epidural space
- Any subject that requires an epidural needle longer than 4.0 inches
- Any procedure requiring use of CSE needles
- Any contraindication to neuraxial anesthesia
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 |
|---|---|---|
| BrightPointData from the BrightPoint device during epidural placement will be collected in real time on a tablet with pre-programmed software including tissue color and light reflectance with time stamps of when epidural space is entered as voiced by clinician per LOR. | Device | BrightPoint Epidural |
Primary outcome
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.
Time frame: Up to 90 minutes
This is measured as a Yes or No response.
16 secondary outcomes
Number of times epidural accessed while using BrightPoint device as measured by clinical log
Time frame: Up to 90 minutes
Number of times epidural catheter was used during the procedure as measured by clinical log
Time frame: Up to 20 minutes
Number of adverse events as measured by clinician log
Time frame: Up to 90 minutes
Number of times the BrightPoint device provided real-time secondary confirmation of Loss of Residence (LOR) as measured by clinician log
Time frame: Up to 90 minutes
Number of times the BrightPoint device provided beneficial qualitative/quantitative clinical information to help complete the epidural as measured by clinician log.
Time frame: Up to 90 minutes
Number of times clinician experienced the haptic feel of entering the ligamentum flavum (LF) as measured by clinician log
Time frame: Up to 90 minutes
Number of times clinician experienced LOR after entering the epidural space as measured by clinician log
Time frame: Up to 90 minutes
Number of times clinician experienced the haptic sensation of the needle contacting any tissue that was not expected as measured by clinician log
Time frame: Up to 90 minutes
Number of times there were issues with catheterization as measured by clinician log
Time frame: Up to 90 minutes
Number of times there were issues achieving pain management as measured by clinician log
Time frame: Up to 4 hours
Number of times the device indicated the needle tip was entering the LF as measured by clinician log
Time frame: Up to 20 minutes
Number of times the device showed a significant change of color from the light in LF to the dark in ES as measured by clinician log
Time frame: Up to 90 minutes
Number of times the device showed a significant change of reflectance from high in LF to low in ES as measured by clinician log
Time frame: Up to 90 minutes
Number of times the LOR and BrightPoint device agreed as measured by clinician log
Time frame: Up to 90 minutes
Number of times coring was observed during procedure as measured by clinician log
Time frame: Up to 90 minutes
Number of times the BrightPoint interfered with the ability to perform the epidural placement in the usual manner with LOR and haptic feedback as measured by clinician log
Time frame: Up to 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
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Lidocaine Patch for Epidural Placement Pain in Laboring Women
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Active, not recruiting
How the Method of Bladder Emptying After Epidural Placement in Labor Affects Postpartum Voiding
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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. This study is not recruiting at the moment.
Lora Levin, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrightPoint in people with Epidural Placement, run by University Hospitals Cleveland Medical Center 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately. (time frame: Up to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.