Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Device: G132 system, Beijing PINS Medical Co., China

Study type: Interventional

Funder types: Other

Identifiers

NCT05895981

KY20232100

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Sacral nerve stimulation

Experimental group

Treatment:

Device: G132 system, Beijing PINS Medical Co., China