Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 and up

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

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorPT. Prodia Stem Cell Indonesia
Industry-sponsored
Locations1 site (Denpasar, Bali)
StatusRecruiting
StartedDecember 15, 2025
Main results expectedMarch 15, 2026
Study endsAugust 15, 2026
Registry record updatedJuly 23, 2026
Trial IDNCT07723313 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

  • Prof. dr. I.G.N.G. Ngoerah General Hospital
    Denpasar, Bali, Indonesia
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.