Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT07114159
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the Mayo score', 'timeFrame': 'From baseline to 8 years', 'description': 'The range of Mayo score is 0-12, and higher scores mean worse outcome'}], 'secondaryOutcomes': [{'measure': 'Clinical remission', 'timeFrame': 'From baseline to 8 years', 'description': 'overall mayo score ≤2 \\[and no individual subscore \\>1\\]'}, {'measure': 'Clinical response', 'timeFrame': 'From baseline to 8 years', 'description': 'defined as the reduction of baseline scores by ≥3 points'}, {'measure': 'Change from baseline in the Truelove and Witts Severity Index', 'timeFrame': 'From baseline to 8 years', 'description': 'Truelove and Witts Severity Index'}, {'measure': 'Endoscopic remission', 'timeFrame': 'From baseline to 8 years', 'description': 'defined as Mayo endoscopic score ≤ 1'}, {'measure': 'Fecal calprotectin levels', 'timeFrame': 'From baseline to 8 years', 'description': 'fecal sample'}, {'measure': 'erythrocyte sedimentation rate levels', 'timeFrame': 'From baseline to 8 years', 'description': 'blood sample'}, {'measure': 'C reactive protein levels', 'timeFrame': 'From baseline to 8 years', 'description': 'blood sample'}, {'measure': 'Inflammatory Bowel Disease Questionnaire Score', 'timeFrame': 'From baseline to 8 years', 'description': 'The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome'}, {'measure': 'Hospital Anxiety and Depression scale score', 'timeFrame': 'From baseline to 8 years', 'description': 'The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome'}, {'measure': 'Gut microbiota profile', 'timeFrame': 'From baseline to 8 years', 'description': 'fecal sample'}, {'measure': 'The Pittsburgh Sleep Quality Index', 'timeFrame': 'From baseline to 8 years', 'description': 'higher scores mean worse outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 years\n* ulcerative colitis diagnosed for at least 3 mouths.\n* Mayo score 6-12, Mayo endoscopic score 2-3 points\n* resistant to medical treatment\n\nExclusion Criteria:\n\n* Treatment-naive ulcerative colitis (no previous treatment)\n* Acute severe ulcerative colitis\n* Currently taking any biologicals\n* Previous surgical treatment or severe colitis at imminent risk of surgery\n* infective colitis\n* Other systemic diseases\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT07114159', 'briefTitle': 'Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'KY20232100-extension'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacral nerve stimulation', 'interventionNames': ['Device: Sacral nerve stimulation']}], 'interventions': [{'name': 'Sacral nerve stimulation', 'type': 'DEVICE', 'description': 'Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol', 'armGroupLabels': ['Sacral nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Wan', 'role': 'CONTACT', 'email': '408127528@qq.com', 'phone': '+8615529202305'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jian Wan', 'role': 'CONTACT', 'email': '408127528@qq.com', 'phone': '15529202305'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}