Robot-assisted surgery for nerve entrapment pain relief
Official title: Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)
Run by Ubosga · NCT06578767 · Data updated 2026-11-12
This study is testing if robot-assisted surgery can help people with chronic pelvic pain caused by nerve entrapment feel better when other treatments haven't worked.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Ubosga Academic / other |
| Locations | 1 site (Bordeaux, Gironde) |
| Status | Recruiting |
| Started | July 31, 2024 |
| Main results expected | July 2029 |
| Study ends | July 2033 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT06578767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with diagnosed pudendal and inferior cluneal nerve entrapment who have not found relief through medical treatments.
✕Probably not a fit
Patients without positive 'Nantes criteria' or those unsuitable for surgery or general anesthesia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a robot-assisted laparoscopic approach to decompress the pudendal and inferior cluneal nerves in patients suffering from chronic pelvic pain. It focuses on patients who have not responded to medical treatment and have specific diagnostic criteria indicating nerve entrapment. The study will assess changes in pain levels, anxiety, depression, post-traumatic stress syndrome, and overall quality of life over a one-year follow-up period.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic pain and improve the quality of life for patients with pudendal and inferior cluneal neuralgias.
How similar studies have gone: Previous studies have shown the feasibility of minimally invasive approaches for similar conditions, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * Patients presenting a pudendal and inferior cluneal entrapment neuralgia with 5 positive"Nantes criteria", and failure of the medical treatment * Patient having given consent after reading the information note Exclusion Criteria: * Absence of any "Nantes criteria", * Patient non suitable for surgery/general anesthesia
Where it's running
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Ubosga
Bordeaux, Gironde, France Recruiting
Study contacts
- Principal investigator: Olivier Celhay, M.D — Ubosga
- Study coordinator: Olivier Celhay, M.D
- Email: celhay.ubsg33@gmail.com
- Phone: +33(0)5 56 11 61 44
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Conventional vs High-Voltage Long-Duration Pulsed Radiofrequency for pudendal nerve pain
This trial will try two pulsed radiofrequency approaches to see which one relieves pudendal nerve pain better for adults whose pain hasn't improved with standard treatments.
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Evaluating nerve injections for treating pudendal neuralgia pain
This study is testing if injections of lidocaine into the pudendal nerve can help adults with pudendal neuralgia pain who haven't found relief from regular medications.
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Program to improve nerve healing after laparoscopic surgery for chronic pelvic pain
This study is testing a robot-assisted surgery to see if it can help people with chronic pelvic pain from nerve issues feel better and heal more effectively after other treatments haven't worked.
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Comparing two methods for pudendal nerve block in pelvic pain treatment
This study is testing two different ways to give a nerve block to see which one helps women with pelvic pain feel better.
-
Using closed-loop spinal cord stimulation to treat chronic pelvic pain
This study is testing a new spinal cord stimulation treatment to see if it can help people with chronic pelvic pain feel better and improve their quality of life.
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.