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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device | Device | Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months |
| Time to Return To Work Among Employed Subjects (RTW) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Pistorio, MD | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Associates | Fort Walton Beach | Florida | 32547 | United States | ||
| Vero Orthopaedics |
This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.
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Subjects could choose between having both hands treated (bilateral) at the same time if both hands met study criteria, or having one hand treated (unilateral) in the study. Bilateral patients with both hands treated are reported based on their averaged score, where applicable.
Enrollment in the ROBUST study began on February 16, 2023, and 149 subjects were enrolled. Enrollment was completed on June 30, 2023. Per the protocol, a subject was considered enrolled once they had signed the informed consent form, met all inclusion and exclusion criteria, and completed carpal tunnel release with Ultrasound guidance (CTR-US) using the UltraGuideCTR device.
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| ID | Title | Description |
|---|---|---|
| FG000 | Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2022 |
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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.
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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. |
| 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. | 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:
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. | 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. | 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. | 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. | 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. | 3 Months |
| Vero Beach |
| Florida |
| 32960 |
| United States |
| Georgia Hand, Shoulder & Elbow | Atlanta | Georgia | 30309 | United States |
| Bluegrass Orthopaedics | Lexington | Kentucky | 40509 | United States |
| University of Nevada, Las Vegas | Las Vegas | Nevada | 89128 | United States |
| The Bone & Joint Surgery Clinic | Raleigh | North Carolina | 27609 | United States |
| New Braunfels Orthopaedic Surgery and Sports Medicine | New Braunfels | Texas | 78130 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CTR-US | Participants who underwent Carpal Tunnel Release with Ultrasound Guidance (CTR-US) using the UltraGuideCTR device in the ROBUST Study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change at 3 months | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 Months |
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| Secondary | 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. | Time to return to normal daily activities | Posted | Mean | Standard Deviation | Days | 3 Months |
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| Secondary | 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. | Time to return to work in days among employed subjects. 102/149 subjects were analyzed as only employed subjects were asked for return to work data. | Posted | Mean | Standard Deviation | Days | 3 Months |
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| Secondary | 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. | Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) change at 3 months. 146 out of 149 eligible participants completed the BCTQ-FSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 Months |
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| Secondary | Michigan Hand Questionnaire (MHQ) | Michigan Hand Questionnaire (MHQ) is a validated, hand-specific questionnaire consisting of 37 questions in 6 domains:
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. | Michigan Hand Questionnaire (MHQ) change at 3 months. 145 out of 149 eligible participants completed the MHQ at the 3-month visit and were analyzed for this endpoint. 4 participants did not complete the assessment. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 Months |
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| Secondary | 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. | Numeric Pain Scale change at 3 months | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 Months |
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| Secondary | 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. | EuroQol 5-Dimension 5-Level (EQ-5D-5L) change at 3 months | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 Months |
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| Secondary | 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. | Participants with Procedure and/or Device-Related Adjudicated Adverse Events | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | 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. | Global satisfaction score at 3 months | Posted | Mean | Standard Deviation | units on a scale | 3 Months |
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Adverse events were collected out to 1 year.
AE could be reported 2 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. If the site is notified of a potential AE by the subject, confirmation of the AE will occur by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CTR-US | Participants who underwent Carpal Tunnel Release with Ultrasound Guidance (CTR-US) using the UltraGuideCTR device in the ROBUST Study. | 0 | 149 | 0 | 149 | 1 | 149 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve Injury Median (non-digital) | Musculoskeletal and connective tissue disorders | Other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Stegner, Vice President Clinical Affairs | Sonex Health, Inc. | (888) 518-8780 | astegner@sonexhealth.com |
| May 5, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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