RecruitingRecruiting
Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
NCT05895981 · Xijing Hospital
In plain English
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Official title
An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
About this study
Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents.
The aim of this exploratory Clinical Trial is to evaluate the safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis.
Eligibility 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
Study design
Enrollment target: 15 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-20
Estimated completion: 2027-12-01
Last updated: 2025-12-04
Interventions
Device: G132 system, Beijing PINS Medical Co., China
Primary outcomes
- • Change from baseline in the Mayo score at week 12 (12 weeks)
Sponsor
Xijing Hospital · other
Contacts & investigators
ContactJian Wan · contact · 408127528@qq.com · +8615529202305
InvestigatorKaichun Wu, PhD · study_chair, Air Force Military Medical University, China
All locations (1)
Xijing HospitalRecruiting
Xi'an, Shaanxi, China