Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 8:34 PM
Study NCT ID:
NCT05636657
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)", 'timeFrame': 'At baseline', 'description': "The Simple Ultrasound Score for Crohn's Disease \\[SUS-CD\\] is constituted by Bowel wall thickness (BWT) and colour Doppler. BWT：\\<3 mm gets 0 score, 3 to 4.9 mm gets 1 score, 5 to 7.9 mm gets 2 scores, and intestinal wall thickness of ≥8 mm gets 3scores. Colour Doppler score：No or single vessel gets 0 score, 2-5 vessels per cm2 gets 1 score, \\>5 vessels per cm2 gets 2 scores."}, {'measure': "the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)", 'timeFrame': 'At baseline', 'description': "The CECDAI was designed to evaluate three main parameters of Crohn's disease: inflammation (A), extent of disease (B), and stricture (C), in both the proximal and distal segments of the small bowel. The final score was calculated by adding the two segmental scores: CECDAI =(\\[A1×B1\\] +C1) +(\\[A2×B2\\] +C2)."}, {'measure': "the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)", 'timeFrame': 'at the third month of treatment', 'description': "The Simple Ultrasound Score for Crohn's Disease \\[SUS-CD\\] is constituted by Bowel wall thickness (BWT) and colour Doppler. BWT：\\<3 mm gets 0 score, 3 to 4.9 mm gets 1 score, 5 to 7.9 mm gets 2 scores, and intestinal wall thickness of ≥8 mm gets 3scores. Colour Doppler score：No or single vessel gets 0 score, 2-5 vessels per cm2 gets 1 score, \\>5 vessels per cm2 gets 2 scores."}, {'measure': "the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)", 'timeFrame': 'at the third month of treatment', 'description': "The CECDAI was designed to evaluate three main parameters of Crohn's disease: inflammation (A), extent of disease (B), and stricture (C), in both the proximal and distal segments of the small bowel. The final score was calculated by adding the two segmental scores: CECDAI =(\\[A1×B1\\] +C1) +(\\[A2×B2\\] +C2)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intestinal Color Ultrasound', 'Capsule Endoscopy', 'SUS-CD', 'CECDAI'], 'conditions': ['Digestive System Disease', 'Inflammatory Bowel Diseases', 'Crohn Disease', 'Crohn Disease of Small Intestine']}, 'descriptionModule': {'briefSummary': "The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and at the third month of treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.", 'detailedDescription': "The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. Active lesions under intestinal color ultrasound were defined as SUS-CD ≥ 1, and active lesions under capsule endoscopy were defined as CECDAI ≥ 3.9. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and 3 months after treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease;\n* 2.At the time of inclusion, there were active lesions under color ultrasound or capsule endoscopy;\n* 3.Voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n* 1.Patients with contraindications for capsule endoscopy;\n* 2.In the judgment of the investigator, it is not suitable to participate in this study."}, 'identificationModule': {'nctId': 'NCT05636657', 'briefTitle': "Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': "Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease", 'orgStudyIdInfo': {'id': 'NFEC-2022-346'}}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Xinmei Zhao, Applicant', 'role': 'CONTACT', 'email': 'xmzhao914@163.com', 'phone': '13268270713'}], 'facility': 'NanFang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xinmei Zhao, doctor', 'role': 'CONTACT', 'email': 'xmzhao914@163.com', 'phone': '13268270713'}], 'overallOfficials': [{'name': 'Xinmei Zhao, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}