Active Ulcerative ColitisPRIMICISTIMNCT02748590
Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)
A study testing InterStim II Neurostimulator Model 3058 in people with Active Ulcerative Colitis, run by Nantes University Hospital at 1 site in France.
Trial summary
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Ulcerative Colitis
- What is being tested?
- InterStim II Neurostimulator Model 3058
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
Read the detailed description
Neuromodulation is a validated option for the treatment of fecal incontinence. Safety of this original approach has been confirmed by several studies. New indications for this minimally-invasive procedure are actually under evaluation particularly in the fields of irritable bowel syndrome and chronic constipation with promising results. Its mechanism of action remains partially unknown and the target of neuromodulation is not limited to the anal sphincter but the whole colonic motility seems to be influenced by this therapeutic approach. Moreover, recent experimental studies have shown that neuromodulation was able to reinforce the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis.
Subsequently, preliminary results in human have shown improvement of inflammation in patients suffering from inflammatory bowel diseases. In fact, despite recent improvement in medical therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several patients are suffering from disabling chronic active disease. In those cases of refractory diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery. This approach is a curative option, but leads to a significant morbidity and frequent functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases). Moreover, in limited distal disease (left colon and rectum) the surgical option seems to be unadapted and many patients remain symptomatic and suffer chronic active disease.
The aim of this study will be to assess in a prospective pilot study the efficacy of ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to the left side of the colon and improving the quality of life of the patients.
- Conditions
- Active Ulcerative Colitis
- Being tested
- InterStim II Neurostimulator Model 3058
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim II Neurostimulator Model 3058Device
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
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation | Experimental | Not described Receives: Device: InterStim II Neurostimulator Model 3058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (15)
Assess the Remission at Week 16 ( Mayo score)
Remission is defined by a Mayo score ≤ 1 point.
Measured: 16 weeks
Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
The response is defined as a decrease of at least 1 point in the item assessment by the physician and at least 1 point from the 3 other items with no increase in the other dimensions of the score.
Measured: 16 weeks
Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
The answer Clinic is defined as a decrease of at least 3 points in the score Clinic dimension compared to baseline.
Measured: 16 weeks
Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
Endoscopic response corresponds to a decrease of at least 1 point in the endoscopic score
Measured: 16 weeks
Assess the histological response at Week 8 and Week 16 (Geboes Score)
Mucosal healing is defined by a score of Geboes less than or equal to 1 of the biopsy examination
Measured: 16 weeks
Assess the biological response at Week 8 and Week 16 (C-reactive protein)
Biological response is defined as a decrease of C-reactive protein
Measured: 16 weeks
Assess the biological response at Week 8 and Week 16 (Calprotectin)
Biological response is defined as a decrease of fecal calprotectin.
Measured: 16 weeks
Evaluate the symptom's resolution at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
The resolution is defined by bleeding Ulcerative Colitis Disease Activity Index sub-score 0
Measured: 16 weeks
Evaluate the urgencies cessation at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
The resolution is defined by bleeding Ulcerative Colitis Disease Activity Index sub-score 0
Measured: 16 weeks
Evaluate the cessation of rectal bleeding at Week 8, Week 16
Cessation of rectal bleeding is defined as rectal bleeding Ulcerative Colitis Disease Activity Index sub-score of 0
Measured: 16 weeks
Evaluate the immunosuppressive drugs at Week 8 and Week 16
Absence or decreasing in immunosuppressive drugs during the follow-up
Measured: 16 weeks
Evaluate the need for steroids at Week 8 and Week 16
The need for steroid treatment at least once during the follow-up period
Measured: 16 weeks
Evaluate the tolerance of neuromodulation in Ulcerative Colitis patients at Week 3, Week 8 and Week 16
Tolerance of neuromodulation is stated by symptom specific scale
Measured: 16 weeks
Evaluate the quality of life of the patients at Week 8 and Week 16 (Scale The Short Form 36)
Quality of life is evaluated with The Short Form 36 scale
Measured: 16 weeks
Assess abdominal discomfort for weeks at Week 8 and Week 16
Bristol Stool Scale
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748590
- Sponsor's protocol ID
- RC15_0448
- Acronym
- PRIMICISTIM
- Status last verified
- Mar 2020
- First submitted
- 14 Apr 2016
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02748590
- Acronym / sponsor ID
- PRIMICISTIM / RC15_0448
- Conditions
- Active Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
Detailed description
Neuromodulation is a validated option for the treatment of fecal incontinence. Safety of this original approach has been confirmed by several studies. New indications for this minimally-invasive procedure are actually under evaluation particularly in the fields of irritable bowel syndrome and chronic constipation with promising results. Its mechanism of action remains partially unknown and the target of neuromodulation is not limited to the anal sphincter but the whole colonic motility seems to be influenced by this therapeutic approach. Moreover, recent experimental studies have shown that neuromodulation was able to reinforce the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis.
Subsequently, preliminary results in human have shown improvement of inflammation in patients suffering from inflammatory bowel diseases. In fact, despite recent improvement in medical therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several patients are suffering from disabling chronic active disease. In those cases of refractory diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery. This approach is a curative option, but leads to a significant morbidity and frequent functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases). Moreover, in limited distal disease (left colon and rectum) the surgical option seems to be unadapted and many patients remain symptomatic and suffer chronic active disease.
The aim of this study will be to assess in a prospective pilot study the efficacy of ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to the left side of the colon and improving the quality of life of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation | Experimental | Device: InterStim II Neurostimulator Model 3058 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| InterStim II Neurostimulator Model 3058The 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 | Device | Neuromodulation |
Primary outcome
Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)
Time frame: 8 weeks
Clinical and endoscopic remission as measured by the Mayo score ≤ 2 points without any criteria> 1 point to week 8
15 secondary outcomes
Assess the Remission at Week 16 ( Mayo score)
Time frame: 16 weeks
Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
Time frame: 16 weeks
Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
Time frame: 16 weeks
Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
Time frame: 16 weeks
Assess the histological response at Week 8 and Week 16 (Geboes Score)
Time frame: 16 weeks
Assess the biological response at Week 8 and Week 16 (C-reactive protein)
Time frame: 16 weeks
Assess the biological response at Week 8 and Week 16 (Calprotectin)
Time frame: 16 weeks
Evaluate the symptom's resolution at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
Time frame: 16 weeks
Evaluate the urgencies cessation at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
Time frame: 16 weeks
Evaluate the cessation of rectal bleeding at Week 8, Week 16
Time frame: 16 weeks
Evaluate the immunosuppressive drugs at Week 8 and Week 16
Time frame: 16 weeks
Evaluate the need for steroids at Week 8 and Week 16
Time frame: 16 weeks
Evaluate the tolerance of neuromodulation in Ulcerative Colitis patients at Week 3, Week 8 and Week 16
Time frame: 16 weeks
Evaluate the quality of life of the patients at Week 8 and Week 16 (Scale The Short Form 36)
Time frame: 16 weeks
Assess abdominal discomfort for weeks at Week 8 and Week 16
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Related trials for Active Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruitingPhase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Moderately to Severely Active Ulcerative Colitis
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
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 InterStim II Neurostimulator Model 3058 in people with Active Ulcerative Colitis, run by Nantes University Hospital 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 1 Apr 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score) (time frame: 8 weeks). 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 1 Apr 2020.