Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-28 @ 12:00 PM
Study NCT ID:
NCT01264835
Status:
TERMINATED
Last Update Posted:
2012-03-02
First Post:
2010-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mschwier@its.jnj.com', 'phone': '513-337-1172', 'title': 'Michael Schwiers, Principal Biostatistician', 'organization': 'Ethicon Endo-Surgery'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No analyses are being reported for the primary outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Slotted Anoscope', 'description': 'Subjects consenting to have hemorrhoidectomy with the slotted anoscope', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Rectal Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding dictionary'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedure Duration (Surgery Time)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Slotted Anoscope', 'description': 'Subjects consenting to have hemorrhoidectomy with the slotted anoscope'}], 'paramType': 'MEAN', 'timeFrame': 'Time of surgery', 'description': 'Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Slotted Anoscope', 'description': 'Subjects consenting to have hemorrhoidectomy with the slotted anoscope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Slotted Anoscope', 'description': 'Subjects consenting to have hemorrhoidectomy with the slotted anoscope'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Slow Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2010-12-17', 'resultsFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-01', 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Duration (Surgery Time)', 'timeFrame': 'Time of surgery', 'description': 'Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Excisional Hemorrhoidectomy']}, 'descriptionModule': {'briefSummary': 'This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are at least 18 years of age\n* Are willing to give consent and comply with evaluation and treatment schedule\n* Meet institutional criteria for excisional hemorrhoidectomy\n* Are able to understand and complete study questionnaires.\n\nExclusion Criteria:\n\n* Previous Hemorrhoid surgery\n* Chronic daily narcotic use\n* Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure\n* Internal hemorrhoids that may be suitable for office management (surgeon discretion)\n* Fecal or urinary incontinence\n* Inflammatory Bowel Disease (Crohns, ulcerative colitis)\n* Acutely thrombosed hemorrhoids (surgeon discretion)\n* Evidence of acute sepsis or the presence of a fistula\n* Anal stricture.'}, 'identificationModule': {'nctId': 'NCT01264835', 'briefTitle': 'Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery'}, 'orgStudyIdInfo': {'id': 'CI-10-0003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Slotted Anoscope', 'type': 'DEVICE', 'description': 'SA411'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Saint Joseph's Hospital of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}