Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 11:42 AM
Study NCT ID:
NCT00995735
Status:
UNKNOWN
Last Update Posted:
2009-10-15
First Post:
2009-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMTN Study- International Prospective Multicenter Trial on Clinical NOTES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-14', 'studyFirstSubmitDate': '2009-10-14', 'studyFirstSubmitQcDate': '2009-10-14', 'lastUpdatePostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NOTES', 'Natural Orifice Translumenal Endoscopic surgery', 'Cholecystectomy', 'Appendectomy', 'Endoscopy', 'Laparoscopy', 'Minimally invasive surgery', 'clinical trials'], 'conditions': ['Gastrointestinal Surgery', 'Natural Orifice Surgery']}, 'referencesModule': {'references': [{'pmid': '18027043', 'type': 'BACKGROUND', 'citation': 'Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008 Feb;22(2):542-7. doi: 10.1007/s00464-007-9646-5. Epub 2007 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to clinical applications, but is still limited in the literature to small casuistic reports. A preliminary prospective evaluation of postoperative results of the early casuistic of Natural orifice Surgery for many indications may show advantages and disadvantages of the methods. The IMTN Multicenter Trial for Clinical NOTES was and early results are described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to Natural Orifice Surgery with local IRB aproval for human trials.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients submitted to elective surgery\n\nExclusion Criteria:\n\n* emergency surgery High ASA risk patients'}, 'identificationModule': {'nctId': 'NCT00995735', 'acronym': 'IMTN', 'briefTitle': 'IMTN Study- International Prospective Multicenter Trial on Clinical NOTES', 'organization': {'class': 'OTHER', 'fullName': 'IMTN NOTES Research Group'}, 'officialTitle': 'IMTN Study- International Prospective Multicenter Trial on Clinical NOTES', 'orgStudyIdInfo': {'id': '0209.0.314.000-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transgastric', 'description': 'Patients submitted to Transgastric NOTES surgery', 'interventionNames': ['Procedure: Cholecystectomy', 'Procedure: Appendectomy']}, {'label': 'Transvaginal', 'description': 'Patients submitted to Transvaginal surgery', 'interventionNames': ['Procedure: Cholecystectomy', 'Procedure: Appendectomy']}], 'interventions': [{'name': 'Cholecystectomy', 'type': 'PROCEDURE', 'description': 'Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.', 'armGroupLabels': ['Transgastric', 'Transvaginal']}, {'name': 'Appendectomy', 'type': 'PROCEDURE', 'description': 'Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.', 'armGroupLabels': ['Transgastric', 'Transvaginal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ricardo Zorron', 'role': 'CONTACT', 'phone': '+552191914698'}, {'name': 'Ricardo Zorron, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Municipal Lourenco Jorge', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Ricardo Zorron, MD, PhD', 'role': 'CONTACT', 'email': 'rzorron@terra.com.br', 'phone': '+552191914698'}], 'overallOfficials': [{'name': 'Ricardo Zorron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brazilian College of Surgeons CBC'}, {'name': 'Chisunnami Palanivelu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Indian Society of Laparoscopic Surgery'}, {'name': 'Manuel Galvao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Society of Brazilian Digestive Endoscopy SOBED'}, {'name': 'Almino Ramos', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brazilian College of Surgeons CBC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IMTN NOTES Research Group', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ricardo Zorron, Professor and Chairman, MD, PhD', 'oldOrganization': 'Brazilian College of Surgeons CBC'}}}}