Vesair Continued Access Trial | NCT03082118

Studies
Vesair Continued Access Trial

NCT03082118

Sponsor

Solace Therapeutics, Inc.

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Stress Urinary Incontinence

Interventions

Vesair Bladder Control System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2017Actual

Primary Completion Date

Jan 15, 2019Actual

Completion Date

Jan 15, 2019Actual

First Submitted Date

Mar 11, 2017

First Submission Date that Met QC Criteria

Mar 11, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2019

Last Update Posted Date

Jul 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vesair Arm	Experimental	Subjects treated with the Vesair Bladder Control System at enrollment.	Device: Vesair Bladder Control System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vesair Bladder Control System	Device	Intravesical balloon	Vesair Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement on patient-reported outcomes	Improvement reported on questionnaires	3-12 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in leakage events	Reduction in leakage events reported on a voiding diary	3-12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post-menopausal women with SUI or stress predominant mixed incontinence
Maximum score on IQOL of 60
Positive cough test for leakage
Willing to undergo procedures
Free from infection
Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

SUI due to SUI
Urge-predominant mixed incontinence
Incontinence of neurogenic etiology
2 or more UTIs in past year and 1 in past 3 months
Surgery for SUI in the past 6 months
taking medication that can be used to treat SUI
taking medication that affects urinary symptoms for less than 3 months
undergoing biofeedback
Grade 3 or worse cystocele
last menstrual period within 12 months
oral progesterone or estrogen in the past 12 months
BMI > 40
involuntary detrusor contractions or discomfort during bladder filling
previous stage III or worse cancer
previous cancer of the urinary tract
previous symptoms for early stage cancer in the past 2 years
anticoagulation therapy other than aspirin
history of prosthetic heart valve
neurological or connective tissue condition or disease affecting bladder function
known allergy to device components

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente Urology		Los Angeles	California	90027	United States
Kaiser Permanente Urogynecology

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided