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Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy

NCT03479229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-05-19

No results posted yet for this study

Summary

This study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth. Participants will be randomized to either active or sham treatment and followed for 12 months.

Conditions

  • Female Sexual Dysfunction

Interventions

DEVICE

Geneveve Treatment

The active treatment group will receive a treatment dose of 90 J/cm\^2

DEVICE

Sham Treatment

The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm\^2.

Sponsors & Collaborators

  • Viveve Inc.

    lead INDUSTRY

Principal Investigators

  • Stacie Bell, PhD · Viveve Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2020-03-15
Completion
2020-03-15
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03479229 on ClinicalTrials.gov