Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
Not applicable · Testing G132 system, Beijing PINS Medical Co., China · 1 site · Xijing Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing G132 system, Beijing PINS Medical Co., China (a device) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- age ≥18 years
- ulcerative colitis diagnosed for at least 3 mouths.
- Mayo score 6-12, Mayo endoscopic score 2-3 points
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- Start date: 2023-07-20.
- Main results expected around 2026-03-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Change from baseline in the Mayo score at week 12 (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Xijing Hospital |
| Enrollment | 15 (estimated) |
| Start date | 2023-07-20 |
| Primary completion (est.) | 2026-03-01 |
| First posted | 2023-06-09 |
| Last updated | 2025-12-04 |
| Official title | An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients |
| ClinicalTrials.gov ID | NCT05895981 |
Interventions
- G132 system, Beijing PINS Medical Co., China (Device)
Neuromodulation was performed according to the usual protocol
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hospital | Xi'an, Shaanxi | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.