Carpal Tunnel SyndromeROBUSTNCT05675046
Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
A study testing Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device in people with Carpal Tunnel Syndrome and CTS, run by Sonex Health, Inc. at 7 sites in United States.
Trial summary
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, CTS
- What is being tested?
- Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Feb 2023to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Clinical diagnosis of unilateral or bilateral idiopathic CTS
- CTS-6 score >12 in target hand*
- Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*
- Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*
- Subject agrees to complete follow-up questionnaires over a 24-month period
- Subject has a valid smart phone number and/or email address to receive and answer follow-up questionnaires
Who cannot join
- Prior surgery on the target wrist or hand with the exception of (a) trigger finger release or similar minor finger procedure (e.g., digital ganglion cyst removal, foreign body removal) that has clinically recovered, or release for DeQuervain's syndrome (1st dorsal compartment) that has clinically recovered*
- History of prior surgical CTR in the target hand*
- History of infection in the target hand*
- History of prior surgery in the non-target hand, including CTR, within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
- Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*
- Corticosteroid injection in the target hand within 6 weeks of study procedure date*
Show all 23Show fewer
- Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)*
- Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side*
- Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side*
- Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side*
- Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side*
- Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side*
- Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
- Amyloidosis
- Chronic renal insufficiency requiring dialysis
- Diabetes not controlled by a stable dose of medication
- Uncontrolled thyroid disease
- Pregnant or planning pregnancy in the next 24 months
- Workers' compensation subjects
- Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
- Subject has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations
- Note: An asterisk () denotes that this criterion must be applied to the target hand for unilateral CTR-US procedures, or to both hands for simultaneous bilateral CTR-US procedures.
- Clinically significant is defined as likely to interfere with the performance of the procedure in a safe and/or effective manner.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Georgia Hand, Shoulder & Elbow
Atlanta, Georgia, 30309
Orthopedic Associates
Fort Walton Beach, Florida, 32547
University of Nevada, Las Vegas
Las Vegas, Nevada, 89128
Bluegrass Orthopaedics
Lexington, Kentucky, 40509
New Braunfels Orthopaedic Surgery and Sports Medicine
New Braunfels, Texas, 78130
The Bone & Joint Surgery Clinic
Raleigh, North Carolina, 27609
Vero Orthopaedics
Vero Beach, Florida, 32960
About this study
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.
Read the detailed description
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting reporting the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).
- Conditions
- Carpal Tunnel Syndrome, CTS
- Being tested
- Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device
- Keywords
- Ultrasound Guided Carpal Tunnel Release, CTR-US, Office-Based, In Office, UltraGuideCTR
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR deviceDevice
Also called UltraGuideCTR
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study.
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device | Experimental | Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. Receives: Device: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.
Measured: Baseline and 3 Months
Secondary outcomes (8)
Time to Return To Normal Daily Activities (RTA)
Time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.
Measured: 3 Months
Time to Return To Work Among Employed Subjects (RTW)
Time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.
Measured: 3 Months
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change score in BCTQ-FSS from baseline to the 3-month follow-up are reported. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Measured: Baseline and 3 Months
Michigan Hand Questionnaire (MHQ)
Michigan Hand Questionnaire (MHQ) is a validated, hand-specific questionnaire consisting of 37 questions in 6 domains:
- Overall hand function
- Activities of daily living
- Work performance
- Pain
- Aesthetics
- Satisfaction
The total score ranges from 0 to 100. Higher scores indicate better hand performance; lower scores indicate lower hand performance. Mean change in the total MHQ score at the 3-month follow-up relative to baseline is reported.
Measured: Baseline and 3 Months
Numeric Pain Scale
The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline and 3-month follow-up are reported. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity. Bilateral patients with both hands treated are reported based on their averaged score.
Measured: Baseline and 3 Months
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change score in the EQ-5D-5L from baseline to the 3-month follow-up are reported. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.
Measured: Baseline and 3 Months
Number of Participants With Device and/or Procedure Related Adverse Events
Participants with adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device or definitely related or probably related to the procedure will be included in this endpoint. The number of device- or procedure-related AEs within 90 days of treatment will represent an endpoint of the study.
Measured: 3 Months
Global Satisfaction
Subjects were asked to rate their satisfaction with the carpal tunnel release procedure. The global satisfaction scale ranges from 1 to 5, with 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neither Satisfied nor Dissatisfied, 4 = Satisfied and 5 = Very Satisfied. The mean satisfaction score at the 3-month follow-up is reported. Bilateral patients with both hands treated are reported based on their averaged score. Higher scores indicate higher satisfaction; lower scores indicate lower satisfaction.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start16 Feb 2023
- Primary completion24 Sep 2023
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with the Carpal tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in an office-based setting.
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonex Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Pistorio, MD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675046
- Sponsor's protocol ID
- 90098-TP
- Acronym
- ROBUST
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2022
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
- ClinicalTrials.gov ID
- NCT05675046
- Acronym / sponsor ID
- ROBUST / 90098-TP
- Conditions
- Carpal Tunnel Syndrome, CTS
- Keywords
- Ultrasound Guided Carpal Tunnel Release, CTR-US, Office-Based, In Office, UltraGuideCTR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Sonex Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.
Detailed description
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting reporting the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with the Carpal tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in an office-based setting.
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device | Experimental | Device: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR deviceParticipants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age
- Clinical diagnosis of unilateral or bilateral idiopathic CTS
- CTS-6 score >12 in target hand*
- Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*
- Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*
Key exclusion criteria (23 listed)
- Prior surgery on the target wrist or hand with the exception of (a) trigger finger release or similar minor finger procedure (e.g., digital ganglion cyst removal, foreign body removal) that has clinically recovered, or release for DeQuervain's syndrome (1st dorsal compartment) that has clinically recovered*
- History of prior surgical CTR in the target hand*
- History of infection in the target hand*
- History of prior surgery in the non-target hand, including CTR, within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
- Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*
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 |
|---|---|---|
| Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR deviceAlso: UltraGuideCTRParticipants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. | Device | Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device |
Primary outcome
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Time frame: Baseline and 3 Months
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.
8 secondary outcomes
Time to Return To Normal Daily Activities (RTA)
Time frame: 3 Months
Time to Return To Work Among Employed Subjects (RTW)
Time frame: 3 Months
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Time frame: Baseline and 3 Months
Michigan Hand Questionnaire (MHQ)
Time frame: Baseline and 3 Months
Numeric Pain Scale
Time frame: Baseline and 3 Months
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Baseline and 3 Months
Number of Participants With Device and/or Procedure Related Adverse Events
Time frame: 3 Months
Global Satisfaction
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.
Related trials for Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
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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.
Ashley Pistorio, MD principal investigator
University of Nevada, Las Vegas
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device in people with Carpal Tunnel Syndrome and CTS, run by Sonex Health, Inc. at 7 sites 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 7 inclusion and 23 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) (time frame: Baseline and 3 Months). 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 6 Jan 2026.