Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04715893
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ostomy Belt Use Associated Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life as measured by SQOLS', 'timeFrame': 'Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use', 'description': 'Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stoma Ileostomy', 'Stoma Colostomy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt\n* 18 - 70 years old\n* Willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Patients without stoma or unwilling to wear ostomy belt.\n* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.'}, 'identificationModule': {'nctId': 'NCT04715893', 'briefTitle': 'Ostomy Belt Use Associated Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Ostomy Belt Use Associated Quality of Life', 'orgStudyIdInfo': {'id': '20201333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ostomy belt group', 'description': 'Participants in this group will receive ostomy belts for eight weeks.', 'interventionNames': ['Other: Ostomy belt']}], 'interventions': [{'name': 'Ostomy belt', 'type': 'OTHER', 'description': 'Stealth ostomy belt continuous for eight weeks', 'armGroupLabels': ['Ostomy belt group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Vanessa Hui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Surgery', 'investigatorFullName': 'Vanessa Hui', 'investigatorAffiliation': 'University of Miami'}}}}