Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)
PRIMICISTIM
1 other identifier
interventional
8
1 country
1
Brief Summary
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedApril 1, 2020
March 1, 2020
3.6 years
April 14, 2016
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)
Clinical and endoscopic remission as measured by the Mayo score ≤ 2 points without any criteria\> 1 point to week 8
8 weeks
Secondary Outcomes (15)
Assess the Remission at Week 16 ( Mayo score)
16 weeks
Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
16 weeks
Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
16 weeks
Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
16 weeks
Assess the histological response at Week 8 and Week 16 (Geboes Score)
16 weeks
- +10 more secondary outcomes
Study Arms (1)
Neuromodulation
EXPERIMENTALInterventions
The neuromodulation will be carried out according to the usual protocol: Hospitalization for the establishment of percutaneous electrode in the operating room under general anesthesia with fluoroscopic control. The pacemaker startup will be performed within 12h after surgery
Eligibility Criteria
You may qualify if:
- Active Ulcerative Colitis diagnosed on criteria Lennard Jones (31) for at least 1 year
- \> 18 yo
- E1 - E2 disease or extended to transverse colon but not beyond the hepatic flexure (endoscopic pictures)
- resistant to medical treatment: active after introduction for at least 8 weeks of maintenance treatment (immunosuppressive or anti-TNF)
- Activity score \>5 and endoscopic score \>2
- Absence of bacterial infection in progress (Clostridium difficile)
- Affiliated with a social protection scheme and had signed an informed consent
You may not qualify if:
- Severe forms requiring hospitalization an intravenous treatment or immediate surgery
- infectious colitis or proctitis
- Prednisone\> 20 mg / d
- Contraindications to the use of neuromodulator
- Corticosteroid therapy by intravenous route
- Pregnant women
- Major Trust
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nantes
Nantes, 44000, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2016
First Posted
April 22, 2016
Study Start
June 1, 2016
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
April 1, 2020
Record last verified: 2020-03