RECRUITINGINTERVENTIONAL
Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
G132 system, Beijing PINS Medical Co., China
Neuromodulation was performed according to the usual protocol
Locations (1)
Xijing Hospital
Xi'an, Shaanxi, China