Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-16 @ 11:23 PM
Study NCT ID:
NCT03310658
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2017-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zip-Stitch™ for Vaginal Cuff Closure in Total 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': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Ease of Use', 'timeFrame': 'Immediately following procedure', 'description': 'Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.'}], 'secondaryOutcomes': [{'measure': 'Vaginal Cuff Closure', 'timeFrame': 'During procedure.', 'description': 'Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care.'}, {'measure': 'Vaginal Cuff Closure Time', 'timeFrame': 'During Procedure.', 'description': 'Procedural time from uterine excision to successful vaginal cuff closure.'}, {'measure': 'Total Surgical Time', 'timeFrame': 'During Procedure.', 'description': 'Total procedural time.'}, {'measure': 'Device Use Learning Curve assessed with a Surgeon Survey', 'timeFrame': 'Assessed immediately following study completion during surgeon survey.', 'description': 'Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.'}, {'measure': 'Sexual Discomfort', 'timeFrame': 'Assessed at 1 and 6 week follow-up visits.', 'description': 'Measurement of subject discomfort during sexual activity following completion of surgical procedure. Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Total Laparoscopic Hysterectomy']}, 'descriptionModule': {'briefSummary': 'ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.\n\nTen subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated Informed Consent Form\n* Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up\n* Female, age 18 years or older\n* Indicated for Total Laparoscopic Hysterectomy\n\nExclusion Criteria:\n\n* HIV\n* Hepatitis C\n* Diabetics\n* Use of systemic corticosteroids\n* History of pelvic irradiation\n* Active infection\n* History of bleeding problems/hemophilia\n* Cancer\n* Cases in which vaginal cuff closure is intended to be performed robotically\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03310658', 'briefTitle': 'Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZSX Medical LLC'}, 'officialTitle': 'Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study', 'orgStudyIdInfo': {'id': 'ZHP01-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Study Site: UANL', 'description': 'As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy.', 'interventionNames': ['Device: Zip-Stitch Soft Tissue Closure System']}], 'interventions': [{'name': 'Zip-Stitch Soft Tissue Closure System', 'type': 'DEVICE', 'description': 'The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.', 'armGroupLabels': ['Single Study Site: UANL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Dan Mazzucco, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ZSX Medical LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZSX Medical LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}