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Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST) (ROBUST)

Primary Purpose

Carpal Tunnel Syndrome, CTS

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Guided Carpal Tunnel Release (CTR-US)
Sponsored by
Sonex Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Ultrasound Guided Carpal Tunnel Release, CTR-US, Office-Based, In Office

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥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 Exclusion Criteria: 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* 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.

Sites / Locations

  • Orthopedic Associates
  • Vero Orthopaedics
  • Georgia Hand, Shoulder & Elbow
  • Bluegrass Orthopaedics
  • University of Nevada, Las Vegas
  • The Bone & Joint Surgery Clinic
  • New Braunfels Orthopaedic Surgery and Sports Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CTR-US

Arm Description

Ultrasound Guided Carpal Tunnel Release (CTR-US)

Outcomes

Primary Outcome Measures

Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (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 change in BCTQ-SSS score at the 3-month follow-up relative to baseline.

Secondary Outcome Measures

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 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.
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
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 change in BCTQ-FSS score at the 3-month follow-up relative to baseline.
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 Change in the total MHQ score as well as each of its 6 domains score at the 3-month follow-up relative to baseline.
Numeric Pain Scale
Subjects will be asked to rate their wrist pain severity on a scale of 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". The change in Numeric Pain Scale score at the 3-month follow-up relative to baseline.
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
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. The change in EQ-5D-5L score at the 3-month follow-up relative to baseline.
Device and/or Procedure Related Adverse Events
Incidence of device- or procedure-related AEs within 90 days of treatment.
Global Satisfaction
Subjects will be asked to rate their satisfaction with the carpal tunnel release procedure and how likely they are to recommend their carpal tunnel release procedure to a friend or colleague.

Full Information

First Posted
December 29, 2022
Last Updated
September 26, 2023
Sponsor
Sonex Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05675046
Brief Title
Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
Acronym
ROBUST
Official Title
Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
November 12, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonex Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, CTS
Keywords
Ultrasound Guided Carpal Tunnel Release, CTR-US, Office-Based, In Office

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter prospective single-arm trial of subjects with symptomatic CTS treated with CTR-US in an office-based setting.
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTR-US
Arm Type
Experimental
Arm Description
Ultrasound Guided Carpal Tunnel Release (CTR-US)
Intervention Type
Device
Intervention Name(s)
Ultrasound Guided Carpal Tunnel Release (CTR-US)
Other Intervention Name(s)
UltraGuideCTR
Intervention Description
The UltraGuideCTR is a commercially available medical device specifically developed to facilitate CTR-US. The device is a single-use, hand-held device that is inserted into the carpal tunnel through a small (typically < 5 mm) wrist incision using continuous US guidance. The working tip of the UltraGuideCTR consists of two inflatable balloons that border a centrally located, retractable retrograde cutting knife. When inflated with sterile saline, the balloons increase the diameter of the tip from 4 mm to 8 mm. After the tip is positioned within the transverse safe zone of the carpal tunnel, the balloons are inflated to create space in the carpal tunnel, the blade is activated, and the TCL is transected in a retrograde manner. Following TCL transection, the blade is recessed, the balloons deflated, and the device is removed. The TCL is probed to ensure a complete release. The entire procedure is performed using US guidance.
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Description
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 change in BCTQ-SSS score at the 3-month follow-up relative to baseline.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Time to Return To Normal Daily Activities (RTA)
Description
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 Frame
3 Months
Title
Time to Return To Work Among Employed Subjects (RTW)
Description
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 Frame
3 Months
Title
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Description
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 change in BCTQ-FSS score at the 3-month follow-up relative to baseline.
Time Frame
3 Months
Title
Michigan Hand Questionnaire (MHQ)
Description
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 Change in the total MHQ score as well as each of its 6 domains score at the 3-month follow-up relative to baseline.
Time Frame
3 Months
Title
Numeric Pain Scale
Description
Subjects will be asked to rate their wrist pain severity on a scale of 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". The change in Numeric Pain Scale score at the 3-month follow-up relative to baseline.
Time Frame
3 Months
Title
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Description
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. The change in EQ-5D-5L score at the 3-month follow-up relative to baseline.
Time Frame
3 Months
Title
Device and/or Procedure Related Adverse Events
Description
Incidence of device- or procedure-related AEs within 90 days of treatment.
Time Frame
3 Months
Title
Global Satisfaction
Description
Subjects will be asked to rate their satisfaction with the carpal tunnel release procedure and how likely they are to recommend their carpal tunnel release procedure to a friend or colleague.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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 Exclusion Criteria: 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* 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Pistorio, MD
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Associates
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
Vero Orthopaedics
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Georgia Hand, Shoulder & Elbow
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Bluegrass Orthopaedics
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
University of Nevada, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
The Bone & Joint Surgery Clinic
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
New Braunfels Orthopaedic Surgery and Sports Medicine
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.

Learn more about this trial

Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)

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