Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01218269
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2010-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
U-clip Pilot Study in Plastic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flap failure rate compared to published rate for conventional suture anastomoses', 'timeFrame': 'will be measured 3 months postoperative (+/- 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.', 'timeFrame': 'data collected at 3 months postoperative (+/- 2 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anastomoses'], 'conditions': ['Microvascular Anastomoses']}, 'descriptionModule': {'briefSummary': 'This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.', 'detailedDescription': 'Within Scott \\& White, a total of 25 free flaps will be performed using U-clips for microvascular anastomoses in lieu of traditional suturing techniques. Each of these free flaps may be in individual patients or two anastomoses may be included in one patient. Historical controls will be used for comparison of complication rates of U-clip versus sutured anastomoses. Postoperatively, the study participants will be evaluated at 2 weeks (+/- 1 week) and at 3 months (+/- 1 month) follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either gender\n* any ethnicity\n* patient requiring free tissue transfer for complex wound coverage or reconstruction\n* patient having arterial anastomotic diameter of at least 2 mm\n* patient capable of giving informed consent\n\nExclusion Criteria:\n\n* less than 18 years of age\n* allergy to nitinol or any of its components (nickel or titanium)\n* pregnancy\n* known coagulopathy'}, 'identificationModule': {'nctId': 'NCT01218269', 'briefTitle': 'U-clip Pilot Study in Plastic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Scott and White Hospital & Clinic'}, 'officialTitle': 'A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses', 'orgStudyIdInfo': {'id': 'SWHospital - 90415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'no arms', 'description': 'all patients will receive the treatment - there is only one arms', 'interventionNames': ['Device: nitinol u-clip']}], 'interventions': [{'name': 'nitinol u-clip', 'type': 'DEVICE', 'otherNames': ['Coalescent Surgical U-CLIPTbl'], 'description': 'The U-clip is comprised of nitinol, an alloy of nickel and titanium.', 'armGroupLabels': ['no arms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott and White Hospital and Clinic', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Raman C Mahabir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scott & White'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scott and White Hospital & Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Raman Chaos Mahabir, MD, MSc, FRCSC', 'oldOrganization': 'Scott and White'}}}}