Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT00889928
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2009-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'SHelsing@its.jnj.com', 'phone': '513-337-3079', 'title': 'Sheryl Helsinger', 'organization': 'Ethicon Endo Surgery, Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No significant limitations. Small sample size limits inference to a larger population, however it did allow to assess whether the procedure was feasible.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cholecystectomy', 'description': 'transvaginal cholecystectomy', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster infection neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urethral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedure Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transvaginal Cholecystectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of Surgery', 'description': 'Completion of procedure - transvaginal removal of the gallbladder', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects on whom the procedure was attempted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cholecystectomy', 'description': 'transvaginal cholecystectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cholecystectomy', 'description': 'transvaginal cholecystectomy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '6.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', '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': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2009-04-28', 'resultsFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-01', 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Completion', 'timeFrame': 'Day of Surgery', 'description': 'Completion of procedure - transvaginal removal of the gallbladder'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gallbladder disease', 'cholecystectomy', 'gallbladder disease indicated for cholecystectomy'], 'conditions': ['Gallbladder Disease']}, 'descriptionModule': {'briefSummary': "The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nWomen will be enrolled in this study who:\n\n1. Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;\n2. At least 18 years of age;\n3. Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;\n4. ASA Classification I or II (Appendix II);\n5. Have a negative serum pregnancy test (for women of childbearing potential); and\n6. Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.\n\nExclusion Criteria\n\nSubjects will be excluded from the study for any of the following:\n\n1. BMI \\> 35;\n2. Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);\n3. Suspicion of gallbladder cancer, tumor, polyps, or mass;\n4. Acute cholecystitis or acute pancreatitis;\n5. Presence of common bile duct stones;\n6. History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test);\n7. Pelvic Inflammatory Disease;\n8. Evidence of abdominal abscess or mass;\n9. Diffuse peritonitis;\n10. Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;\n11. Clinical diagnosis of sepsis;\n12. History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;\n13. History of peritoneal or vaginal trauma;\n14. Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;\n15. Planned concurrent surgical procedure;\n16. Prior or planned major surgical procedure within 30 days before or after study procedure;\n17. History of transvaginal surgery;\n18. History of (or symptomatic for) abdominal adhesions;\n19. Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;\n20. Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox;\n21. Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or\n22. Any condition which precludes compliance with the study (Investigator discretion)."}, 'identificationModule': {'nctId': 'NCT00889928', 'acronym': 'NOTES', 'briefTitle': 'A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance', 'nctIdAliases': ['NCT00821704'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery'}, 'officialTitle': 'A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance', 'orgStudyIdInfo': {'id': 'CI-08-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cholecystectomy', 'description': 'transvaginal cholecystectomy', 'interventionNames': ['Device: NOTES GEN 1 Toolbox']}], 'interventions': [{'name': 'NOTES GEN 1 Toolbox', 'type': 'DEVICE', 'description': '* Articulating Hook Knife\n* Articulating Snare\n* Articulating Needle Knife\n* Articulating Graspers\n* Articulating Biopsy Forceps\n* Steerable Flex Trocar with Rotary Access Needle\n* Flexible Bipolar Hemostasis Forceps\n* Flexible Maryland Dissector', 'armGroupLabels': ['cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Eric Hungness, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}