Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01429805
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2011-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2011-09-05', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy.', 'timeFrame': 'Treatment (Day 0)'}], 'secondaryOutcomes': [{'measure': 'Reduction in external traction time.', 'timeFrame': 'Treatment (Day 0)'}, {'measure': 'Investigator-related adequacy of central compartment visualization with use of the investigational device.', 'timeFrame': 'Treatment (Day 0)'}, {'measure': 'Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.', 'timeFrame': 'Treatment (Day 0)'}, {'measure': 'The occurrence of serious adverse events by 6-week follow-up rated by the investigator to be probably or definitely related to the investigational device.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip arthroscopy'], 'conditions': ['Hip Arthroscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain information on the safety and performance of HipJack Balloon Spacer to access the central compartment of the hip and maintain intra-articular hip joint distraction during arthroscopy of the central compartment of the hip.', 'detailedDescription': 'The HipJack Kit is intended to maintain distraction of the joint during hip arthroscopy. This study will evaluate the Kit in clinical sites outside of the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for unilateral arthroscopic procedure of the hip\n\nExclusion Criteria:\n\n* Active infection sepsis or osteomyelitis\n* Body mass index (BMI) of 40 or greater\n* Open wounds of the hip or leg area\n* Moderate or severe degenerative hip disease or hip joint space \\<3 mm\n* Large pincer, coxa profunda or protrusio\n* Retroverted acetabulum\n* Compromised ligamentum teres or ligamentum teres dysplasia\n* Previous hip surgery or arthroscopy on the target hip\n* Hip injury due to high-energy trauma\n* Hip fracture or hip dislocation on the target hip\n* Metabolic disorders that may impair bone formation\n* Osteomalacia or moderate to severe osteoporosis, rapid joint destruction, marked bone loss or bone resorption noted on x-ray\n* Severe neurosensory deficits\n* Inadequate joint space distraction with external traction to allow for insertion of HipJack device\n* Any condition that is a relative or absolute contraindication to hip arthroscopy\n* Pregnant or lactating\n* History of venous thrombosis or known coagulopathy'}, 'identificationModule': {'nctId': 'NCT01429805', 'acronym': 'BAHA-I', 'briefTitle': 'Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pivot Medical Inc.'}, 'officialTitle': 'Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy', 'orgStudyIdInfo': {'id': 'PR01662'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HipJack Balloon Spacer', 'type': 'DEVICE', 'description': 'Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pellenberg', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87245, 'lon': 4.79394}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Clinic', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts and The London NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Manoj Ramachandran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts and The London NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pivot Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}