NCT02261974

VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Viveve Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is planned. This study is designed to demonstrate that the active treatment (i.e., Viveve Procedure) is superior to the sham treatment for the primary effectiveness and safety endpoints. Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active treatment group or sham group. The active treatment group will receive a treatment dose of 90 J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2. Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post treatment. Final data will be reported at 6 months for active and sham treatments.

Conditions

• Vaginal Laxity Following Childbirth
• Sexual Function Following Childbirth

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-10-10
• Last updated: 2018-08-28
• Results posted: 2017-12-27

Locations

9 sites across 4 countries: Canada, Italy, Japan, Spain

Regulatory

• FDA-regulated device study