Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-24 @ 9:55 PM
Study NCT ID:
NCT02590666
Status:
UNKNOWN
Last Update Posted:
2016-03-09
First Post:
2015-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2015-10-25', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).', 'timeFrame': '3 months after resection of the polyp, repeat hysteroscopy to assess recurrence'}], 'primaryOutcomes': [{'measure': 'To assess the tolerability of polypectomy using a validated visual analogue pain scale', 'timeFrame': 'we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endometrial Polyps']}, 'descriptionModule': {'briefSummary': 'Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.\n\nThe aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .\n\nHypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must be informed about the study, and sign the informed consent\n\nExclusion Criteria:\n\n* Positive Pap smear test\n* Pregnancy\n* Uterine malignancy\n* Abnormal uterine bleeding'}, 'identificationModule': {'nctId': 'NCT02590666', 'briefTitle': 'Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers', 'orgStudyIdInfo': {'id': 'PolypectomyCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bipolar electrode', 'description': 'Polyps resection with bipolar electrode', 'interventionNames': ['Procedure: Bipolar Polypectomy', 'Device: Bipolar electrode']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microscissors or graspers', 'description': 'Polyps resection with microscissors or graspers', 'interventionNames': ['Procedure: Mechanical Polypectomy', 'Device: Microscissors or graspers']}], 'interventions': [{'name': 'Bipolar Polypectomy', 'type': 'PROCEDURE', 'description': 'Polyps resection with bipolar electrode', 'armGroupLabels': ['Bipolar electrode']}, {'name': 'Mechanical Polypectomy', 'type': 'PROCEDURE', 'description': 'Polyps resection with microscissors or graspers', 'armGroupLabels': ['Microscissors or graspers']}, {'name': 'Bipolar electrode', 'type': 'DEVICE', 'description': 'Bipolar electrode used to performs polypectomy', 'armGroupLabels': ['Bipolar electrode']}, {'name': 'Microscissors or graspers', 'type': 'DEVICE', 'description': 'Mechanical instruments used to performs polypectomy', 'armGroupLabels': ['Microscissors or graspers']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefano Angioni', 'investigatorAffiliation': 'University of Cagliari'}}}}