Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01471756
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2011-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-05', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Two Devices used in EMR', 'timeFrame': '1 year', 'description': 'To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" .'}], 'secondaryOutcomes': [{'measure': 'Compare the Use of Two Injectates', 'timeFrame': '1 year', 'description': 'To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sessile neoplasms', 'flat neoplasms', 'gastric cancer'], 'conditions': ['Neoplasms', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.', 'detailedDescription': 'The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sessile colorectal polyp\n* laterally spreading lesions as defined by Paris Classification type II and \\> 1 cm or greater\n\nExclusion Criteria:\n\n* Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma\n* Inflammatory bowel disease patients\n* Coagulopathy ( INR\\> 1.5) that cannot be corrected'}, 'identificationModule': {'nctId': 'NCT01471756', 'briefTitle': 'Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps', 'orgStudyIdInfo': {'id': '10-008104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iSnare with Gonak solution', 'interventionNames': ['Procedure: Standard of Care Procedure as described in ARM']}, {'type': 'EXPERIMENTAL', 'label': 'Snaremaster braided snare with Gonak solution', 'interventionNames': ['Procedure: Standard of Care Procedure as described in ARM']}, {'type': 'EXPERIMENTAL', 'label': 'iSnare with saline solution', 'interventionNames': ['Procedure: Standard of Care Procedure as described in ARM']}, {'type': 'EXPERIMENTAL', 'label': 'Snaremaster braided snare with saline solution', 'interventionNames': ['Procedure: Standard of Care Procedure as described in ARM']}], 'interventions': [{'name': 'Standard of Care Procedure as described in ARM', 'type': 'PROCEDURE', 'description': 'Standard of Care Procedure as described in ARM', 'armGroupLabels': ['Snaremaster braided snare with Gonak solution', 'Snaremaster braided snare with saline solution', 'iSnare with Gonak solution', 'iSnare with saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Timothy A Woodward, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Endoscopy', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Timothy Woodward', 'investigatorAffiliation': 'Mayo Clinic'}}}}