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Vesair Balloon Confirmatory Trial (VECTOR)

NCT03794206 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-13

No results posted yet for this study

Summary

Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Vesair Balloon

Treatment with Vesair Balloon for one year

Sponsors & Collaborators

  • Solace Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles Rardin, M.D. · Women and Infants Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2019-08-26
Completion
2022-04-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794206 on ClinicalTrials.gov