Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT05332132
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ex Vivo Study of the Heracure Device for Intra-uterine Morcellation After Vaginal or Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device or procedure related Adverse Event (AE)', 'timeFrame': 'Intra-operation', 'description': 'Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline.'}], 'secondaryOutcomes': [{'measure': 'Device Success', 'timeFrame': 'Intra-operation', 'description': 'Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal or Laparoscopic Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '36930660', 'type': 'DERIVED', 'citation': 'Pomeranz M, Schonman R, Yagur Y, Tamir Yaniv R, Klein Z, Daykan Y. An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study. PLoS One. 2023 Mar 17;18(3):e0282149. doi: 10.1371/journal.pone.0282149. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.', 'detailedDescription': 'The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is undergoing hysterectomy due to benign gynecologic disease\n\nExclusion Criteria:\n\n* Subject is not suspected of malignancy'}, 'identificationModule': {'nctId': 'NCT05332132', 'briefTitle': 'Ex Vivo Study of the Heracure Device for Intra-uterine Morcellation After Vaginal or Laparoscopic Hysterectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heracure Medical Ltd.'}, 'officialTitle': 'Evaluation of the Heracure Device for Hysterectomy', 'orgStudyIdInfo': {'id': '202019038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrauterine Morcellation of Uteri Post-Surgery', 'description': 'Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)', 'interventionNames': ['Device: Heracure Device']}], 'interventions': [{'name': 'Heracure Device', 'type': 'DEVICE', 'description': 'Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)', 'armGroupLabels': ['Intrauterine Morcellation of Uteri Post-Surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Aisa Kaizler', 'role': 'CONTACT', 'email': 'asia.kaizler@clalit.org.il', 'phone': '097471041'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Gal Meister', 'role': 'CONTACT', 'email': 'galmeist1@gmail.com', 'phone': '0549011128'}], 'overallOfficials': [{'name': 'Gal Meister', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heracure Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}