Amniotic Membrane and Secretome Added to Carpal Tunnel Release
Official title: Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
Run by PT. Prodia Stem Cell Indonesia · NCT07723313 · Data updated 2026-11-12
This trial tests whether adding amniotic membrane and secretome to carpal tunnel surgery helps people with moderate-to-severe CTS recover better than surgery alone.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | PT. Prodia Stem Cell Indonesia Industry-sponsored |
| Locations | 1 site (Denpasar, Bali) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | March 15, 2026 |
| Study ends | August 15, 2026 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07723313 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with moderate-to-severe CTS confirmed by EMG who have persistent symptoms despite conservative care and are eligible for carpal tunnel release.
✕Probably not a fit
Patients with previous carpal tunnel release on the same wrist, wrist trauma or surgery history, or comorbidities that affect nerve healing may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, early-phase study compares standard carpal tunnel release to release with adjunctive amniotic membrane and secretome in adults with moderate-to-severe CTS. Outcomes are measured before surgery and three weeks after using the Boston Carpal Tunnel Questionnaire and electromyography to gauge symptoms, function, and nerve recovery. The design includes a pre- and post-intervention assessment to determine the added benefit of the biological adjuncts. Participants are adults with CTS confirmed by EMG who have not responded to conservative treatment. Key safety and feasibility signals will be monitored as the study explores a potential new option to enhance surgical recovery.
Why it matters
Potential benefit: If successful, the adjunct could improve symptom relief and functional recovery after carpal tunnel release.
How similar studies have gone: Prior studies in related fields have explored biologic adjuncts with mixed results, making this approach exploratory for CTS.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older. * Diagnosed with moderate-to-severe Carpal Tunnel Syndrome (CTS) based on electromyography (EMG) according to the Bland classification. * Persistent CTS symptoms that have not improved with conservative treatment. * Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * Previous carpal tunnel release surgery on the affected wrist. * History of wrist trauma or previous wrist surgery. * Presence of comorbidities that may affect nerve healing or study outcomes, including diabetes mellitus, hypertension, or metabolic disorders. * Symptoms resembling CTS are attributable to other conditions, such as cervical spine or cervical nerve disorders (e.g., cervical radiculopathy).
Where it's running
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Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali, Indonesia Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.