Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT02578667
Status:
WITHDRAWN
Last Update Posted:
2016-05-17
First Post:
2015-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gorbly Compression Device for Use in Image-guided Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study cancelled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2015-10-07', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion.', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasm', 'Sepsis']}, 'descriptionModule': {'briefSummary': "Prospective cohort study. All patients presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage performed under the care of Dr. Issam Kably will become part of the study population. Based on prior imaging and/or imaging at the time of the procedure, patients will fall into two groups, those for whom no compression is necessary to complete the procedure and those for whom compression may provide benefit. These would be selected based on Dr. Kably's experience as a practicing academic, fellowship-trained, and CAQ'ed interventional radiologist. The latter group would then further subdivide into those who give consent for use of the compression device and those who do not consent. Results of each group would be measured including the following: termination versus successful completion of the procedure; adverse events including bleeding or damage to surrounding structures necessitating further medical or surgical intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All-comers presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage .\n\nExclusion Criteria:\n\n* Open surgical or traumatic abdominal wall.\n* Active abdominal wall infection.'}, 'identificationModule': {'nctId': 'NCT02578667', 'briefTitle': 'Gorbly Compression Device for Use in Image-guided Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Gorbly Compression Device for Use in Image-guided Procedures', 'orgStudyIdInfo': {'id': '20150294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Gorbly Compression not needed'}, {'type': 'EXPERIMENTAL', 'label': 'Gorbly Compression may benefit', 'description': 'the use of the Gorbly device with the consent of the patient', 'interventionNames': ['Device: Gorbly Compression Device']}], 'interventions': [{'name': 'Gorbly Compression Device', 'type': 'DEVICE', 'description': 'The compression device provides a way to displace critical structures along the path from skin to target, retract excess body wall tissue, and provide mechanical stabilization in a repeatable and sustainable fashion.', 'armGroupLabels': ['Gorbly Compression may benefit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Issam Kably, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wallace H Coulter Center for Translational Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Issam Kably', 'investigatorAffiliation': 'University of Miami'}}}}