Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Walter Reed National Military Medical Center.
NCT04504019 is a NA study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability). For the primary analysis, change in QuickDASH score will be tracked across the first five occasio
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 |
What the finished NCT04504019 record still lists
NCT04504019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which mOCTR is the first listed.
NCT04504019 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04504019's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI