Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06031051
Status:
UNKNOWN
Last Update Posted:
2023-09-11
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capsule Endoscopy as an Alternative to Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 704}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients who could avoid colonoscopy', 'timeFrame': '6 months', 'description': 'To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE'}], 'secondaryOutcomes': [{'measure': 'CE diagnostic yield and adenoma detection rate (ADR)', 'timeFrame': '6 months', 'description': 'Number of adenoma detected by CE'}, {'measure': 'To compare CE and CC findings', 'timeFrame': '6 months', 'description': 'Compare findings between both techniques'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.', 'detailedDescription': 'Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).\n\nStudy population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years\n\n * Rectal bleeding/haematochezia in patients \\>50 years who have undergone a colonoscopy \\<5 years ago or \\<50 years with no risk factors for CRC\n * Chronic constipation/abdominal distension/abdominal pain/diarrhea\n * Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed\n * Recent change in bowel habits\n * Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease\n\nExclusion Criteria:\n\n* Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis\n* Evaluation following fragmented resection (recurrence ruled out)\n* Patients with a positive FIT\n* Pregnancy or breast-feeding\n* Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.\n* Allergy or known contraindication to the medications and preparations agents used in the procedure."}, 'identificationModule': {'nctId': 'NCT06031051', 'acronym': 'CAPSUCOVID', 'briefTitle': 'Capsule Endoscopy as an Alternative to Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?', 'orgStudyIdInfo': {'id': 'CAPSUCOVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Pillcam Crohn's Capsule Endoscopy and colonoscopy", 'description': "All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy", 'interventionNames': ["Device: Pillcam Crohn's Capsule Endoscopy"]}], 'interventions': [{'name': "Pillcam Crohn's Capsule Endoscopy", 'type': 'DEVICE', 'otherNames': ['Pillcam'], 'description': 'Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy', 'armGroupLabels': ["Pillcam Crohn's Capsule Endoscopy and colonoscopy"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Cruz de Tenerife', 'state': 'Canary Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Zebenzuy Gimeno-García', 'role': 'CONTACT', 'email': 'antozeben@gmail.com'}], 'facility': 'Hospital universitario de Santa Cruz de Tenerife', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'BEGOÑA GONZALEZ SUAREZ', 'role': 'CONTACT', 'email': 'bgonzals@clinic.cat', 'phone': '+34661334362'}], 'facility': 'Hospital clinic of barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Romero Mascarell, MD', 'role': 'CONTACT', 'email': 'cromerom@santpau.cat'}], 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Terrassa', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Montserrat Aceituno Quintanilla', 'role': 'CONTACT', 'email': 'maceituno@mutuaterrassa.es'}], 'facility': 'Hospital Mutua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'BEGOÑA GONZALEZ SUAREZ, MD, PhD', 'role': 'CONTACT', 'email': 'bgonzals@clinic.cat', 'phone': '+34661334362'}, {'name': 'Miguel Urpí Ferreruela, MD', 'role': 'CONTACT', 'email': 'murpi@recerca.clinic.cat'}], 'overallOfficials': [{'name': 'BEGOÑA GONZALEZ SUAREZ, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Begoña González Suárez', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}