NCT06796595 Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
| NCT ID | NCT06796595 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UBOSGA |
| Condition | Pudendal Neuralgia |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-01-23 with a primary completion date of 2027-01-31.
⚠ 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
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).
Eligibility Criteria
Inclusion Criteria: * Patients over 18 years old * Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment * Patient having given consent after reading the information note Exclusion Criteria: * Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications) * Person deprived of liberty or under guardianship * Person under court protection * Pregnant or breast-feeding woman * Minors
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06796595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pudendal Neuralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06796595 currently recruiting?
Yes, NCT06796595 is actively recruiting participants. Contact the research team at celhay.ubsg33@gmail.com for enrollment information.
Where is the NCT06796595 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT06796595 clinical trial?
NCT06796595 is sponsored by UBOSGA. The trial plans to enroll 20 participants.