Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-28 @ 10:31 AM
Study NCT ID:
NCT02334995
Status:
UNKNOWN
Last Update Posted:
2016-01-26
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-24', 'studyFirstSubmitDate': '2015-01-07', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ulcer diameter shrinkage', 'timeFrame': '6-8 weeks', 'description': 'ulcer diameter measured in rectosigmoidoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['solitery rectal ulcer', 'biofeedback', 'dissynergy'], 'conditions': ['Rectal Ulcer']}, 'descriptionModule': {'briefSummary': 'Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer.', 'detailedDescription': 'dyssynergia treating ulcers caused by treatment with biofeedback'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with solitary rectal ulser', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* solitary rectal ulcer in rectosigmoidoscopy\n* type 1 or 3 dissynergic defecation\n* to accept to participate to study and sign informed consent\n\nExclusion Criteria:\n\n* previously applied biofeedback\n* serious psychiatric disorder\n* previous anorectal surgery\n* the presence of active malignancy'}, 'identificationModule': {'nctId': 'NCT02334995', 'briefTitle': 'The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'The Biofeedback Therapy in Solitery Rectal Ulser Patients', 'orgStudyIdInfo': {'id': 'SRUS-BF'}, 'secondaryIdInfos': [{'id': 'SRUS-BF', 'type': 'REGISTRY', 'domain': 'SRUS-BF'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Serhat Bor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ege University Faculty of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Serhat Bor', 'role': 'CONTACT', 'email': 'serhatbor@yahoo.com', 'phone': '+902323905216'}], 'overallOfficials': [{'name': 'Serhat Bor', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr', 'investigatorFullName': 'Serhat Bor', 'investigatorAffiliation': 'Ege University'}}}}