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VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

NCT02261974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2018-08-28

Study results available
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Summary

Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design

The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.

Conditions

  • Vaginal Laxity Following Childbirth
  • Sexual Function Following Childbirth

Interventions

DEVICE

Active Treatment Viveve

Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus

DEVICE

Sham Treatment Viveve

Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus

Sponsors & Collaborators

  • Viveve Inc.

    lead INDUSTRY

Principal Investigators

  • Debbie Wilkerson, PhD · Viveve Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-04-30
Completion
2016-04-30
FDA Device
Yes

Countries

  • Canada
  • Italy
  • Japan
  • Spain

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 NCT02261974 on ClinicalTrials.gov