Post-Market Registry of the Patient Experience When Using UltraGuideCTR for Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

— MISSION  

Official title:

Post-Market Registry of the Patient Experience When Using UltraGuideCTR for Carpal (MISSION)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071468
• Other study ID #: 90154-TP
• Status: Recruiting
• Start date: January 26, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Sonex Health, Inc.
• Contact: Cindy B Grabowski
• Phone: 16122453733
• Email: cgrabowski[@]sonexhealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Multicenter prospective registry of patients with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US).

Description:

Multicenter prospective registry of patients with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) to collect large scale, multidimensional real-world data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age

2. Clinical diagnosis of unilateral or bilateral CTS

3. A clinical decision has been made to perform CTR-US using UltraGuideCTR on one or both hands

4. CTS-6 score >12 in the target hand(s)

5. Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area =10 mm2 in the proximal carpal tunnel region)

6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s)

7. Patient agrees to complete follow-up questionnaires over a 24-month period.

8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

Exclusion Criteria:

1. Patient meets any of the contraindications per Instruction For Use (IFU)

2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• CTS

Intervention

Device:
• Ultrasound Guided Carpal Tunnel Release (CTR-US)
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.

Locations

Country	Name	City	State
United States	Buffalo Surgery Center	Amherst	New York
United States	Aventura Hand Center	Aventura	Florida
United States	Ortho SC	Conway	South Carolina
United States	North Texas Hand Center	Denton	Texas
United States	Tri-State Orthopaedics	Evansville	Indiana
United States	The Orthopaedic Institute	Gainesville	Florida
United States	Cape Cod Orthopaedics	Hyannis	Massachusetts
United States	Sports Orthopedics & Spine	Jackson	Tennessee
United States	Hand Center of Nevada	Las Vegas	Nevada
United States	Bluegrass Orthopaedics	Lexington	Kentucky
United States	The Orthopaedic Hand and Arm Center	Miami Lakes	Florida
United States	Integris Health	Oklahoma City	Oklahoma
United States	Orthopedic Asociates	Saint Louis	Missouri
United States	Mobility Bone and Joint Institute	Salem	New Hampshire
United States	Mendelson Orthopedic PC	Troy	Michigan
United States	Excel Orthopaedic Specialists	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sonex Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 24-month follow-up relative to baseline.	24 Months
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.	24 Months
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.	24 Months
Secondary	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 24-month follow-up relative to baseline.	24 Months
Secondary	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 24-month follow-up relative to baseline.	24 Months
Secondary	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 24-month follow-up relative to baseline.	24 Months
Secondary	Device and/or Procedure Related Adverse Events	Incidence of device- or procedure-related AEs within 24 months of treatment.	24 Months
Secondary	Global Satisfaction with Carpal Tunnel Release Procedure	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 on a scale from 0-10 with 0 being not at all likely and 10 being extremely likely. Satisfaction will be reported with the following options: Very Satisfied, Satisfied, Neither Satisfied or dissatisfied, Dissatisfied or Very dissatisfied.	24 Months