NCT07723313 Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
| NCT ID | NCT07723313 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | PT. Prodia Stem Cell Indonesia |
| Condition | Carpal Tunnel Syndrome (CTS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-12-15 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. This study is a randomized controlled trial with a pre- and post-intervention experimental design to evaluate the effectiveness of adjunctive amniotic membrane combined with secretome in patients with moderate-to-severe CTS undergoing carpal tunnel release surgery. Participants will be randomly assigned to receive either standard surgical treatment alone or surgery with the addition of amniotic membrane and secretome. Clinical and electrophysiological outcomes will be evaluated before surgery and at 3 weeks after the intervention using the Boston Carpal Tunnel Questionnaire (BCTQ) and electromyography (EMG) to assess symptom improvement, functional recovery, and median nerve regeneration.
Eligibility 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).
Frequently Asked Questions
Who can join the NCT07723313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carpal Tunnel Syndrome (CTS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07723313 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07723313 currently recruiting?
Yes, NCT07723313 is actively recruiting participants. Visit ClinicalTrials.gov or contact PT. Prodia Stem Cell Indonesia to inquire about joining.
Where is the NCT07723313 trial being conducted?
This trial is being conducted at Denpasar, Indonesia.
Who is sponsoring the NCT07723313 clinical trial?
NCT07723313 is sponsored by PT. Prodia Stem Cell Indonesia. The trial plans to enroll 30 participants.