Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 5:25 AM
Study NCT ID:
NCT01054534
Status:
TERMINATED
Last Update Posted:
2015-04-13
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Sponsor withdrew funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-21', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the third sacral foramen of the pelvis through US image fusion technology', 'timeFrame': 'at time of procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary incontinence'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of the pelvis to guide a needle to the second sacral foramen using the posterior approach and place a interstim lead.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient consented for Interstim lead placement\n\nExclusion Criteria:\n\n* Patients requesting not to be in the study.\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT01054534', 'briefTitle': 'Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)', 'orgStudyIdInfo': {'id': '09-000293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Placement of interstim lead', 'description': 'Placement of interstim lead using US image fusion technology', 'interventionNames': ['Procedure: Placement of interstim lead']}], 'interventions': [{'name': 'Placement of interstim lead', 'type': 'PROCEDURE', 'description': 'Placement of insterstim lead using US image fusion technology', 'armGroupLabels': ['Placement of interstim lead']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Steven Clendenen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'Traxtal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Steven R. Clendenen', 'investigatorAffiliation': 'Mayo Clinic'}}}}