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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sacral nerve stimulation

Group Type EXPERIMENTAL

G132 system, Beijing PINS Medical Co., China

Intervention Type DEVICE

Neuromodulation was performed according to the usual protocol

Interventions

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G132 system, Beijing PINS Medical Co., China

Neuromodulation was performed according to the usual protocol

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No