Trial record 4 of 6 for:
solace | stress incontinence
Vesair Clinical Trial (VAPOR)
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ClinicalTrials.gov Identifier: NCT04026347 |
Recruitment Status :
Recruiting
First Posted : July 19, 2019
Last Update Posted : June 1, 2020
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Sponsor:
Solace Therapeutics, Inc.
Information provided by (Responsible Party):
Solace Therapeutics, Inc.
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 17, 2019 | ||||||||
First Posted Date ICMJE | July 19, 2019 | ||||||||
Last Update Posted Date | June 1, 2020 | ||||||||
Actual Study Start Date ICMJE | February 1, 2020 | ||||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Composite Endpoint [ Time Frame: 6 months ] Pad weight + I-QOL
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Vesair Clinical Trial | ||||||||
Official Title ICMJE | An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women | ||||||||
Brief Summary | Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Masking Description: Subject and assessor blinded to randomization result Primary Purpose: Treatment
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Condition ICMJE | Stress Urinary Incontinence | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
150 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04026347 | ||||||||
Other Study ID Numbers ICMJE | CD1010 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Solace Therapeutics, Inc. | ||||||||
Study Sponsor ICMJE | Solace Therapeutics, Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Solace Therapeutics, Inc. | ||||||||
Verification Date | May 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |