CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
Active Treatment Viveve +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02261974
NCT02261974N/ACompleted
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VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Viveve Inc.·interventional·Posted Oct 10, 2014·Updated Aug 28, 2018

In Brief

A clinical study evaluating Active Treatment Viveve and Sham Treatment Viveve for Vaginal Laxity Following Childbirth and Sexual Function Following Childbirth. Completed, enrolled 186 participants across 9 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Laxity Following Childbirth, Sexual Function Following Childbirth
CountriesCanada, Italy, Japan, Spain
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 10, 2014
Enrollment StartJan 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.7 years ago

Interventions

Active Treatment Vivevedevice

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

Sham Treatment Vivevedevice

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