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

NCT ID: NCT07114159

Last Updated: 2025-08-11

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

2025-08-02

Study Completion Date

2032-12-01

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

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

Sacral nerve stimulation

Intervention Type DEVICE

Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol

Interventions

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Sacral nerve stimulation

Device: 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 18-65 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

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Wan

Role: CONTACT

15529202305

Facility Contacts

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Jian Wan

Role: primary

+8615529202305

Other Identifiers

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KY20232100-extension

Identifier Type: -

Identifier Source: org_study_id

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