Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis

Sponsor
Xijing Hospital
Study ID
NCT07114159
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sacral nerve stimulation — DEVICE
    Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol

Study Details

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 clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis

Key Dates

First listed
Aug 11, 2025
Start date
Aug 2, 2025
Status verified
Aug 2025
Primary completion
Dec 1, 2032
Completion
Dec 1, 2032

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacral nerve stimulation

Primary Outcome Measure

Change from baseline in the Mayo score [ Time Frame: From baseline to 8 years ]

Central Contacts

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