Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: G132 system, Beijing PINS Medical Co., China.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
Overview
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.
Interventions
- Device G132 system, Beijing PINS Medical Co., China
Neuromodulation was performed according to the usual protocol
Primary outcome measures
- Change from baseline in the Mayo score at week 12 [Time frame: 12 weeks]
Secondary outcome measures (12)
- Change from baseline in the Mayo score at week 24, and 52 [Time frame: 24 and 52 weeks]
- Clinical remission at Week 12, 24, and 52 [Time frame: 12, 24, and 52 weeks]
- Clinical response at Week 12, 24, and 52 [Time frame: 12, 24, and 52 weeks]
- Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52 [Time frame: 12, 24, and 52 weeks]
- Endoscopic remission at Week 12, 24, and 52 [Time frame: 12, 24, and 52 weeks]
- Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
- erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
- C reactive protein levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
- pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
- norepinephrine levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
- interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
- interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52 [Time frame: baseline, 4, 8, 12, 24, and 52 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xijing Hospital — Xi'an
Identifiers
NCT: NCT05895981 · KY20232100