Carpal Tunnel SyndromeCiTRUSNCT05031338
Carpal Tunnel Release Using Ultrasound
An observational study of Carpal Tunnel Syndrome, run by Sonex Health, Inc. at 1 site in United States.
Trial summary
The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Carpal Tunnel Release
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 15 Aug 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled to undergo carpal tunnel release surgery using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance.
Who may be able to join
- Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance
- 18 years of age or older
- Agree to complete questionnaires over a 12-month period
- Valid mobile phone number and email address to receive and answer questions
Who cannot join
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carpal Tunnel Release Using Ultrasound Patient Experience Registry
The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.
Read the detailed description
The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal Tunnel Release
- Keywords
- Carpal Tunnel Release, Ultrasound
- 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 ReleaseDevice
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.
Carpal Tunnel ReleaseProcedure or surgery
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| SX-One MicroKnife with ultrasound guidance | Carpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance Receives: Device: Carpal Tunnel Release; Procedure: Carpal Tunnel Release | |
| Traditional mini-open technique without ultrasound guidance | Carpal Tunnel Release using the traditional mini-open technique without ultrasound guidance Receives: Device: Carpal Tunnel Release; Procedure: Carpal Tunnel Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function.
Measured: 12 months
Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function.
Measured: 12 months
Secondary outcomes (1)
Patient reported time to return to activities
Patient reported time to return to normal activities as measured in days.
Measured: Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start2 Jul 2021
- Primary completion1 Aug 2022
- Study completion15 Aug 2022
Why it stopped: Sponsor changing database systems for ease of use for patient data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sonex Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Smith, MD, Principal investigator, Sonex Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031338
- Sponsor's protocol ID
- CL002
- Acronym
- CiTRUS
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kamel SI, Freid B, Pomeranz C, Halpern EJ, Nazarian LN. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome. AJR Am J Roentgenol. 2021 Aug;217(2):460-468. doi: 10.2214/AJR.20.24383. Epub 2020 Sep 2.
PubMed 32876476Chappell CD, Beckman JP, Baird BC, Takke AV. Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US-Guided Carpal Tunnel Release. J Ultrasound Med. 2020 Apr;39(4):693-702. doi: 10.1002/jum.15146. Epub 2019 Oct 29.
PubMed 31659789Joseph AE, Leiby BM, Beckman JP. Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician. J Ultrasound Med. 2020 Mar;39(3):441-452. doi: 10.1002/jum.15120. Epub 2019 Aug 26.
PubMed 31449326Henning PT, Yang L, Awan T, Lueders D, Pourcho AM. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: Preliminary Clinical Results. J Ultrasound Med. 2018 Nov;37(11):2699-2706. doi: 10.1002/jum.14618. Epub 2018 Apr 2.
PubMed 29608024Latzka EW, Henning PT, Pourcho AM. Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report. PM R. 2018 Oct;10(10):1125-1129. doi: 10.1016/j.pmrj.2018.02.018. Epub 2018 Mar 6.
PubMed 29518589Henning T, Lueders D, Chang K, Yang L. Ultrasound-Guided Carpal Tunnel Release Using Dynamic Expansion of the Transverse Safe Zone in a Patient With Postpolio Syndrome: A Case Report. PM R. 2018 Oct;10(10):1115-1118. doi: 10.1016/j.pmrj.2018.02.016. Epub 2018 Mar 6.
PubMed 29518587Leiby BM, Beckman JP, Joseph AE. Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance. Hand (N Y). 2022 Nov;17(6):1074-1081. doi: 10.1177/1558944720988080. Epub 2021 Jan 29.
PubMed 33511873
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Release Using Ultrasound Patient Experience Registry
- ClinicalTrials.gov ID
- NCT05031338
- Acronym / sponsor ID
- CiTRUS / CL002
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Release, Ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor changing database systems for ease of use for patient data collection
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Sonex Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 1 Sep 2021 (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.
The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.
Detailed description
The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SX-One MicroKnife with ultrasound guidance | – | Device: Carpal Tunnel Release, Procedure: Carpal Tunnel ReleaseCarpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance |
| Traditional mini-open technique without ultrasound guidance | – | Device: Carpal Tunnel Release, Procedure: Carpal Tunnel ReleaseCarpal Tunnel Release using the traditional mini-open technique without ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo carpal tunnel release surgery using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance.
Key inclusion criteria (4 listed)
- Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance
- 18 years of age or older
- Agree to complete questionnaires over a 12-month period
- Valid mobile phone number and email address to receive and answer questions
Key exclusion criteria (1 listed)
- Age less than 18 years
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 ReleaseCarpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance. | Device | SX-One MicroKnife with ultrasound guidance, Traditional mini-open technique without ultrasound guidance |
| Carpal Tunnel ReleaseCarpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance. | Procedure or surgery | SX-One MicroKnife with ultrasound guidance, Traditional mini-open technique without ultrasound guidance |
Primary outcome
Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months
Time frame: 12 months
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function.
Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months
Time frame: 12 months
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function.
1 secondary outcome
Patient reported time to return to activities
Time frame: Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
Results and safety
The study was stopped early (reason given: Sponsor changing database systems for ease of use for patient data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 32876476Kamel SI, Freid B, Pomeranz C, Halpern EJ, Nazarian LN. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome. AJR Am J Roentgenol. 2021 Aug;217(2):460-468. doi: 10.2214/AJR.20.24383. Epub 2020 Sep 2.
- Background: PubMed 31659789Chappell CD, Beckman JP, Baird BC, Takke AV. Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US-Guided Carpal Tunnel Release. J Ultrasound Med. 2020 Apr;39(4):693-702. doi: 10.1002/jum.15146. Epub 2019 Oct 29.
- Background: PubMed 31449326Joseph AE, Leiby BM, Beckman JP. Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician. J Ultrasound Med. 2020 Mar;39(3):441-452. doi: 10.1002/jum.15120. Epub 2019 Aug 26.
- Background: PubMed 29608024Henning PT, Yang L, Awan T, Lueders D, Pourcho AM. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: Preliminary Clinical Results. J Ultrasound Med. 2018 Nov;37(11):2699-2706. doi: 10.1002/jum.14618. Epub 2018 Apr 2.
- Background: PubMed 29518589Latzka EW, Henning PT, Pourcho AM. Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report. PM R. 2018 Oct;10(10):1125-1129. doi: 10.1016/j.pmrj.2018.02.018. Epub 2018 Mar 6.
- Background: PubMed 29518587Henning T, Lueders D, Chang K, Yang L. Ultrasound-Guided Carpal Tunnel Release Using Dynamic Expansion of the Transverse Safe Zone in a Patient With Postpolio Syndrome: A Case Report. PM R. 2018 Oct;10(10):1115-1118. doi: 10.1016/j.pmrj.2018.02.016. Epub 2018 Mar 6.
- Background: PubMed 33511873Leiby BM, Beckman JP, Joseph AE. Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance. Hand (N Y). 2022 Nov;17(6):1074-1081. doi: 10.1177/1558944720988080. Epub 2021 Jan 29.
- Individual participant dataSharing planned: No
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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.
Jay Smith, MD principal investigator
Sonex Health, Inc.
1 site 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, run by Sonex Health, Inc. at 1 site 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Sponsor changing database systems for ease of use for patient data collection). Results are not available in the source record.
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?
Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031338, which also lists 7 linked publications.
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 18 Aug 2022.