Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-27 @ 3:28 AM
Study NCT ID:
NCT06461559
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'timing to return of bowel function', 'timeFrame': '1-5 days', 'description': 'time to return of bowel function after stoma surgery'}], 'secondaryOutcomes': [{'measure': 'ease of stoma infusion', 'timeFrame': '2 weeks prior to surgery to time of surgery', 'description': 'how easy was it for patients to infuse contents'}, {'measure': 'complications', 'timeFrame': '2 weeks prior to surgery to 30 days post operatively', 'description': 'if there are any complications from using the stoma infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stoma Ileostomy', 'Ileostomy; Complications']}, 'descriptionModule': {'briefSummary': "This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a diverting loop ileostomy\n* undergoing evaluation for stoma takedown\n\nExclusion Criteria:\n\n* unable to perform consent\n* unable to perform stoma infusion'}, 'identificationModule': {'nctId': 'NCT06461559', 'briefTitle': 'Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion', 'orgStudyIdInfo': {'id': '810144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ileostomy infusion', 'description': 'perform infusion if ileostomy prior to takedown operation', 'interventionNames': ['Device: antegrade infusion of ileostomy content']}], 'interventions': [{'name': 'antegrade infusion of ileostomy content', 'type': 'DEVICE', 'description': 'infusing the contents of ileostomy output back into intestine of the patient', 'armGroupLabels': ['Ileostomy infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shanglei Liu', 'role': 'CONTACT', 'email': 'ssgaboyan@health.ucsd.edu', 'phone': '858-249-1837'}], 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Shanglei Liu', 'investigatorAffiliation': 'University of California, San Diego'}}}}