Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-12 @ 1:05 AM
Study NCT ID:
NCT03082118
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2017-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vesair Continued Access Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All women enrolled are treated.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2017-03-11', 'studyFirstSubmitQcDate': '2017-03-11', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement on patient-reported outcomes', 'timeFrame': '3-12 months', 'description': 'Improvement reported on questionnaires'}], 'secondaryOutcomes': [{'measure': 'Reduction in leakage events', 'timeFrame': '3-12 months', 'description': 'Reduction in leakage events reported on a voiding diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Single arm study of the Vesair Balloon in postmenopausal women.', 'detailedDescription': 'All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women with SUI or stress predominant mixed incontinence\n* Maximum score on IQOL of 60\n* Positive cough test for leakage\n* Willing to undergo procedures\n* Free from infection\n* Have previously tried (and failed) noninvasive treatment for SUI\n\nExclusion Criteria:\n\n* SUI due to SUI\n* Urge-predominant mixed incontinence\n* Incontinence of neurogenic etiology\n* 2 or more UTIs in past year and 1 in past 3 months\n* Surgery for SUI in the past 6 months\n* taking medication that can be used to treat SUI\n* taking medication that affects urinary symptoms for less than 3 months\n* undergoing biofeedback\n* Grade 3 or worse cystocele\n* last menstrual period within 12 months\n* oral progesterone or estrogen in the past 12 months\n* BMI \\> 40\n* involuntary detrusor contractions or discomfort during bladder filling\n* previous stage III or worse cancer\n* previous cancer of the urinary tract\n* previous symptoms for early stage cancer in the past 2 years\n* anticoagulation therapy other than aspirin\n* history of prosthetic heart valve\n* neurological or connective tissue condition or disease affecting bladder function\n* known allergy to device components'}, 'identificationModule': {'nctId': 'NCT03082118', 'acronym': 'VESICAL', 'briefTitle': 'Vesair Continued Access Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solace Therapeutics, Inc.'}, 'officialTitle': 'Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'CD1007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vesair Arm', 'description': 'Subjects treated with the Vesair Bladder Control System at enrollment.', 'interventionNames': ['Device: Vesair Bladder Control System']}], 'interventions': [{'name': 'Vesair Bladder Control System', 'type': 'DEVICE', 'otherNames': ['Vesair Balloon'], 'description': 'Intravesical balloon', 'armGroupLabels': ['Vesair Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92110', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Urogynecology', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Center for Women', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Institute for Female Pelvic Medicine and Reconstructive Surgery', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Riddle Hospital, Main Line Health', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'West Penn Hospital, Allegheny Health Network', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solace Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}