Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT03467451
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-15', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-03-09', 'lastUpdatePostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions', 'timeFrame': 'One year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polyps of Colon']}, 'descriptionModule': {'briefSummary': 'This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Both male and female over 18 years old with other rectal or colic résections from 10 to 30 mm into the past', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Other rectal or colic résections from 10 to 30 mm into the past\n\nExclusion Criteria:\n\n* Colitis, Crohn Disease or Ulcerative Colitis\n* Intense fibrosis under the lesion'}, 'identificationModule': {'nctId': 'NCT03467451', 'briefTitle': 'Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'officialTitle': 'Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage of the Tip of the Loop', 'orgStudyIdInfo': {'id': 'Mucosectomy with anchorage'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic Mucosectomy', 'type': 'PROCEDURE', 'description': 'Endoscopic Mucosectomy with anchorage of the tip of the loop'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mathieu Pioche', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Edouard Herriot'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean Christophe Saurin', 'investigatorAffiliation': "Société Française d'Endoscopie Digestive"}}}}