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FemPulse Therapy First-in-Human Experience

NCT03874637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-03-14

No results posted yet for this study

Summary

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Conditions

  • Urinary Bladder, Overactive

Interventions

DEVICE

Treament

Placement of the FemPulse System with therapy delivery

DEVICE

Sham Control

Placement of the FemPulse System without therapy delivery

Sponsors & Collaborators

  • FemPulse Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2017-05-17
Completion
2017-05-17
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 NCT03874637 on ClinicalTrials.gov