Robotic DecompressionERISNCT03876977
Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
A study testing Robotic laparoscopic decompression of pudendal nerve entrapment in people with Robotic Decompression, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Primary purpose: Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia. Primary outcomes: Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Robotic Decompression
- What is being tested?
- Robotic laparoscopic decompression of pudendal nerve entrapment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2020to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years old
- Pudendal neuralgia according to Nantes criteria
- pudendal nerve entrapment reachable with robotic transperitoneal approach
Who cannot join
- bilateral pain
- history of pain ≥ 18 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial
Primary purpose:
Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.
Primary outcomes:
Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.
Secondary purposes:
- improvement of quality of life
- study of MRI performance to predict pudendal nerve entrapment topography
- show the feasibility and safety of robotic pudendal nerve decompression
- Conditions
- Robotic Decompression
- Being tested
- Robotic laparoscopic decompression of pudendal nerve entrapment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic laparoscopic decompression of pudendal nerve entrapmentProcedure or surgery
Robotic laparoscopic decompression of pudendal nerve entrapment.
Transperitoneal Laparoscopic Robotic assistance
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive | No intervention | Neuropathic drugs Pudendal infiltration |
| Robotic laparoscopic decompression | Experimental | Robotic laparoscopic decompression of pudendal nerve entrapment. Receives: Procedure: Robotic laparoscopic decompression of pudendal nerve entrapment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points.
Daily collection by the patient over 1 week in real life conditions. Achievement of an average of the scores over 1 week.
Measured: 3-months after surgery or surveillance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start8 Aug 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Why it stopped: recruitments difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic DecompressionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876977
- Sponsor's protocol ID
- 7253
- Acronym
- ERIS
- Status last verified
- Oct 2021
- First submitted
- 12 Mar 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03876977
- Acronym / sponsor ID
- ERIS / 7253
- Conditions
- Robotic Decompression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitments difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary purpose:
Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.
Primary outcomes:
Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.
Secondary purposes:
- improvement of quality of life
- study of MRI performance to predict pudendal nerve entrapment topography
- show the feasibility and safety of robotic pudendal nerve decompression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive | No intervention | –Neuropathic drugs Pudendal infiltration |
| Robotic laparoscopic decompression | Experimental | Procedure: Robotic laparoscopic decompression of pudendal nerve entrapmentRobotic laparoscopic decompression of pudendal nerve entrapment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 70 years old
- Pudendal neuralgia according to Nantes criteria
- pudendal nerve entrapment reachable with robotic transperitoneal approach
Key exclusion criteria (2 listed)
- bilateral pain
- history of pain ≥ 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic laparoscopic decompression of pudendal nerve entrapmentRobotic laparoscopic decompression of pudendal nerve entrapment. Transperitoneal Laparoscopic Robotic assistance | Procedure or surgery | Robotic laparoscopic decompression |
Primary outcome
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
Time frame: 3-months after surgery or surveillance
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. Daily collection by the patient over 1 week in real life conditions. Achievement of an average of the scores over 1 week.
Results and safety
The study was stopped early (reason given: recruitments difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic laparoscopic decompression of pudendal nerve entrapment in people with Robotic Decompression, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitments difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain ) (time frame: 3-months after surgery or surveillance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.