Carpal Tunnel SyndromeMISSIONNCT06071468
Registry of the Patient Experience for Carpal Tunnel Release
An observational study of Carpal Tunnel Syndrome and CTS, run by Sonex Health, Inc. at 33 sites in United States.
Trial summary
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR). 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?
- UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US), Endocscopic CTR and Open CTR
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,424 participants
- Where
- 33 sitesUnited States
- Study dates
- 26 Jan 2024to 31 Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with Carpal Tunnel Syndrome meeting study eligibility criteria. Patients are invited to volunteer to participate at selected study sites.
Who may be able to join
None listed.
Who cannot join
- Patient meets any of the contraindications per Instruction For Use (IFU)
- Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
New Mexico Orthopedics
Albuquerque, New Mexico, 87110
Buffalo Surgery Center
Amherst, New York, 14226
Aventura Hand Center
Aventura, Florida, 33180
The Center
Bend, Oregon, 97701
OrthoSC
Conway, South Carolina, 29526
North Texas Hand Center
Denton, Texas, 76210
University Orthopedics, Inc.
East Providence, Rhode Island, 02914
Twin Cities Orthopedics
Edina, Minnesota, 55435
Slocum Research & Education Foundation
Eugene, Oregon, 97401
Tri-State Orthopaedics
Evansville, Indiana, 47715
The Orthopaedic Group P.C.
Foley, Alabama, 36535
Orthopaedic Associates
Fort Walton Beach, Florida, 32547
North Texas Orthopedics and Spine Center
Fort Worth, Texas, 76244
Orthopaedics Associates of Hartford
Glastonbury, Connecticut, 06033
Prisma Health
Greenville, South Carolina, 29615
Cape Cod Orthopaedics
Hyannis, Massachusetts, 02601-3825
Mississippi Sports Medicine& Orthopedic Center
Jackson, Mississippi, 39202
Sports Orthopedics & Spine
Jackson, Tennessee, 38305
Lakeland Regional Health
Lakeland, Florida, 74137
Hand Center of Nevada
Las Vegas, Nevada, 89123
Dartmouth Hitchcock Clinic
Lebanon, New Hampshire, 03756
Meadville Medical Center
Meadville, Pennsylvania, 16335
Melbourne Hand Center
Melbourne, Florida, 32935
Miami Hand Center
Miami, Florida, 33133
The Orthopaedic Hand and Arm Center
Miami Lakes, Florida, 33014
The Bone&Joint Surgery Clinic
Raleigh, North Carolina, 27609
Mobility Bone and Joint Institute
Salem, New Hampshire, 03079
Phoenix Hand
Scottsdale, Arizona, 85260
Orthopedic Asociates
St Louis, Missouri, 63131
University Orthopedics Center
State College, Pennsylvania, 16801
Mendelson Orthopedic PC
Troy, Michigan, 48080
Vero Orthopaedics
Vero Beach, Florida, 32960
Excel Orthopaedic Specialists
Woburn, Massachusetts, 01801
About this study
Official title: Registry of the Patient Experience for Carpal Tunnel Release (MISSION)
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
Read the detailed description
Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).
- Conditions
- Carpal Tunnel Syndrome, CTS
- Being tested
- UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US), Endocscopic CTR, Open CTR
- Keywords
- Ultrasound Guided Carpal Tunnel Release, CTR-US, ECTR, OCTR, UGCTR
- 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.
UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)Device
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.
Endocscopic CTRProcedure or surgery
Also called ECTR
Endoscopic CTR makes one or two short incisions to introduce instruments for visualizing. The key procedural steps involved in Endoscopic CTR are listed below.
- Following the delivery of anesthesia, the surgeon makes a small wrist incision (usually less than 1.5 cm), with or without a small palmar incision (usually less than 1.5 cm, depending on whether they are using a single portal or double portal technique, respectively.
- A series of dilators and raspers are used to create space in the carpal tunnel and clear synovial tissue from the undersurface fo the TCL.
- A camera attached to a narrow tube (endoscope) is inserted into the carpal tunnel.
- The transverse carpal ligament (which forms the roof of the carpal tunnel) is identified.
- Using specialized cutting instruments and endoscopic guidance, the surgeon transects the TCL.
- Endoscopic visualization and/or probing are used to confirm a complete release.
- The wound(s) is/are typically closed with sutures.
Open CTRProcedure or surgery
Also called OCTR
OCTR is the most commonly used CTR technique in the United States.The key procedural steps involved in OCTR are listed below.
- Following the delivery of anesthesia, an incision is made in the palm directly over the carpal tunnel.
- The surgeon cuts through the palmar fascia to identify the TCL.
- The surgeon transects the TCL with a scalpel and/or similar cutting instruments.
- The surgeon inspects the carpal tunnel to ensure proper decompression.
- The wound is closed with sutures.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Carpal Tunnel Release (CTR-US) | Carpal Tunnel Release using CTR-US technique Receives: Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US) | |
| Open Carpal Tunnel Release (OCTR) | Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR) Receives: Procedure: Open CTR | |
| Endoscopic Carpal Tunnel Release (ECTR) | Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR) Receives: Procedure: Endocscopic CTR |
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)
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.
Measured: 24 Months
Secondary outcomes (5)
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.
Measured: 24 Months
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.
Measured: 24 Months
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.
Measured: 24 Months
Device and/or Procedure Related Adverse Events
Incidence of device- or procedure-related AEs within 24 months of treatment.
Measured: 24 Months
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start26 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,424 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Sonex Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor M Marwin, MD, MBA, Principal investigator, Vero Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071468
- Sponsor's protocol ID
- 90154-TP
- Acronym
- MISSION
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of the Patient Experience for Carpal Tunnel Release (MISSION)
- ClinicalTrials.gov ID
- NCT06071468
- Acronym / sponsor ID
- MISSION / 90154-TP
- Conditions
- Carpal Tunnel Syndrome, CTS
- Keywords
- Ultrasound Guided Carpal Tunnel Release, CTR-US, ECTR, OCTR, UGCTR
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,424 participants (actual)
- Lead sponsor
- Sonex Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Oct 2023 (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.
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
Detailed description
Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Carpal Tunnel Release (CTR-US) | – | Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)Carpal Tunnel Release using CTR-US technique |
| Open Carpal Tunnel Release (OCTR) | – | Procedure: Open CTRCarpal Tunnel Release Using Open Carpal Tunnel Release (OCTR) |
| Endoscopic Carpal Tunnel Release (ECTR) | – | Procedure: Endocscopic CTRCarpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Carpal Tunnel Syndrome meeting study eligibility criteria. Patients are invited to volunteer to participate at selected study sites.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patient meets any of the contraindications per Instruction For Use (IFU)
- Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
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 |
|---|---|---|
| UltraGuideCTR (Device) with 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. | Device | Ultrasound Guided Carpal Tunnel Release (CTR-US) |
| Endocscopic CTRAlso: ECTREndoscopic CTR makes one or two short incisions to introduce instruments for visualizing. The key procedural steps involved in Endoscopic CTR are listed below. 1. Following the delivery of anesthesia, the surgeon makes a small wrist incision (usually less than 1.5 cm), with or without a small palmar incision (usually less than 1.5 cm, depending on whether they are using a single portal or double portal technique, respectively. 2. A series of dilators and raspers are used to create space in the carpal tunnel and clear synovial tissue from the undersurface fo the TCL. 3. A camera attached to a narrow tube (endoscope) is inserted into the carpal tunnel. 4. The transverse carpal ligament (which forms the roof of the carpal tunnel) is identified. 5. Using specialized cutting instruments and endoscopic guidance, the surgeon transects the TCL. 6. Endoscopic visualization and/or probing are used to confirm a complete release. 7. The wound(s) is/are typically closed with sutures. | Procedure or surgery | Endoscopic Carpal Tunnel Release (ECTR) |
| Open CTRAlso: OCTROCTR is the most commonly used CTR technique in the United States.The key procedural steps involved in OCTR are listed below. 1. Following the delivery of anesthesia, an incision is made in the palm directly over the carpal tunnel. 2. The surgeon cuts through the palmar fascia to identify the TCL. 3. The surgeon transects the TCL with a scalpel and/or similar cutting instruments. 4. The surgeon inspects the carpal tunnel to ensure proper decompression. 5. The wound is closed with sutures. | Procedure or surgery | Open Carpal Tunnel Release (OCTR) |
Primary outcome
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Time frame: 24 Months
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.
5 secondary outcomes
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Time frame: 24 Months
Numeric Pain Scale
Time frame: 24 Months
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Time frame: 24 Months
Device and/or Procedure Related Adverse Events
Time frame: 24 Months
Global Satisfaction with Carpal Tunnel Release Procedure
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- 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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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.
Victor M Marwin, MD, MBA principal investigator
Vero Orthopaedics
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome and CTS, run by Sonex Health, Inc. at 33 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 0 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
This study is still under way. Results are not available in the source record yet.
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: 24 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 14 Sep 2026.