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NCT04504019 · ClinicalTrials.gov registry record · NA
Clinical Outcomes of USCTR vs. mOCTR
A NA study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT04504019 is a NA study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 41 participants.
The verdict
NCT04504019, a NA study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single \< 1 cm wrist or palmar incision (USCTR or CTR-US). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, without greater less loss of military duty days. This study is a single-site randomized controlled trial. Participants with CTS will be randomized to a study arm and receive treatment with USCTR vs. traditional mOCTR. All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure, with the primary focus being on outcomes up to 1 year.
Interventions
- PROCEDURE mOCTR
- DEVICE USCTR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2025-08-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04504019
The ClinicalTrials.gov registry entry for NCT04504019 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which mOCTR is the first listed.
NCT04504019 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04504019 about?
NCT04504019 is a clinical study titled "Clinical Outcomes of USCTR vs. mOCTR". Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in t...
What is the current status of trial NCT04504019?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2021-03-02. Estimated completion is 2025-08-06.
What interventions are being tested in trial NCT04504019?
The interventions under investigation include: mOCTR (PROCEDURE), USCTR (DEVICE).
Who is sponsoring clinical trial NCT04504019?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
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