Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT00966420
Status:
COMPLETED
Last Update Posted:
2010-03-30
First Post:
2009-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Traction Assisted Polypectomy of the Intestine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-27', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ablation of lesion in toto', 'timeFrame': '1 week after intervention'}], 'secondaryOutcomes': [{'measure': 'complications after resection', 'timeFrame': 'within one week after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonic Polyps', 'Adenomatous Polyps']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.', 'detailedDescription': 'We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique.\n\nThe traction will be performed by using a haemoclip connected to surgical suture materials. The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection.\n\nThe aim of the study is to show the feasibility of this technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* benign lesions in the large and small intestine\n* diameter of lesion smaller than 3cm\n\nExclusion Criteria:\n\n* malign lesions of the large and small intestine\n* diameter of lesions larger than 3cm'}, 'identificationModule': {'nctId': 'NCT00966420', 'acronym': 'TAEMR', 'briefTitle': 'Traction Assisted Polypectomy of the Intestine', 'organization': {'class': 'OTHER', 'fullName': 'St John of God Hospital, Vienna'}, 'officialTitle': 'Traction Assisted Endoscopic Mucosa Resection (TAEMR)', 'orgStudyIdInfo': {'id': 'SJOG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mucosa resection', 'interventionNames': ['Device: traction assisted endoscopic mucosa resection']}], 'interventions': [{'name': 'traction assisted endoscopic mucosa resection', 'type': 'DEVICE', 'otherNames': ['endoscopic polypectomy'], 'description': 'A haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop.', 'armGroupLabels': ['mucosa resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Departement of Surgery, St John of God Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Bernhard Dauser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St John of God Hospital, Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St John of God Hospital, Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bernhard Dauser, MD', 'oldOrganization': 'St John of God Hospital, Vienna'}}}}