Evaluating sacral nerve stimulation for ulcerative colitis treatment
An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
This study is testing if a new treatment using sacral nerve stimulation can help adults with ulcerative colitis who haven't found relief with standard medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05895981 on ClinicalTrials.gov |
What this trial studies
This exploratory clinical trial aims to assess the safety and efficacy of sacral nerve stimulation in patients suffering from ulcerative colitis. The study will involve patients aged 18-65 who have been diagnosed with ulcerative colitis for at least three months and have not responded to conventional medical treatments. Participants will be monitored for improvements in their condition using the Mayo score system. The intervention will utilize the G132 system developed by Beijing PINS Medical Co.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of ulcerative colitis for at least three months and a Mayo score indicating moderate disease severity.
Not a fit: Patients with treatment-naive ulcerative colitis or those with acute severe conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ulcerative colitis who are resistant to standard medical therapies.
How similar studies have performed: While sacral nerve stimulation has been explored in other gastrointestinal conditions, this specific application for ulcerative colitis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥18 years * ulcerative colitis diagnosed for at least 3 mouths. * Mayo score 6-12, Mayo endoscopic score 2-3 points * resistant to medical treatment Exclusion Criteria: * Treatment-naive ulcerative colitis (no previous treatment) * Acute severe ulcerative colitis * Currently taking any biologicals * Previous surgical treatment or severe colitis at imminent risk of surgery * infective colitis * Other systemic diseases * Pregnancy and lactation
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Jian Wan
- Email: 408127528@qq.com
- Phone: +8615529202305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.