Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-04-14 @ 5:28 PM
Study NCT ID:
NCT02208258
Status:
WITHDRAWN
Last Update Posted:
2016-01-29
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Hospital had initiated a conflicting study, hence the study was terminated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-08-02', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual confirmation that fecal material is diverted into the external collection bag through the device.', 'timeFrame': '120 +/- 8 hours', 'description': 'Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.'}, {'measure': 'Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.', 'timeFrame': '120 +/- 8 hours', 'description': 'Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.'}, {'measure': 'Number of hours for which the device stays on without change or removal.', 'timeFrame': '120 +/- 8 hours', 'description': 'Quantitative measure of duration of device use. The cause of the change or removal will be documented.'}], 'secondaryOutcomes': [{'measure': 'Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.', 'timeFrame': '120 +/- 8 hours', 'description': 'Yes or No response from visual observation of any bleeding on the external periphery of the device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fecal incontinence, consure medical, semi formed stool, stool management system'], 'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.\n* Non-ambulatory, hospitalized patients.\n* History of passage of at least 1 stool in 24 hours.\n\nExclusion Criteria:\n\n* Patients with suspected or confirmed rectal mucosal impairment or pathology.\n* Patients with have undergone descending colon or rectal surgery within the preceding six months.\n* Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.\n* Patients suspected to have impacted stool or is suffering from constipation.\n* Patients with confirmed pregnancy or suspected to be pregnant.\n* Patients that have planned MRI examination over the duration of the study.\n* Patients who have suffered recent cardiac arrest within the preceding 3 months.\n* Patients enrolled in another clinical study or clinical trial.\n* Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).'}, 'identificationModule': {'nctId': 'NCT02208258', 'briefTitle': 'Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Consure Medical Pvt. Ltd.'}, 'orgStudyIdInfo': {'id': 'CON/2013/FI003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Consure 120 Stool Management System', 'type': 'DEVICE', 'otherNames': ['Consure 120 SMS'], 'description': 'Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp HealthCare', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consure Medical Pvt. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}