Completed

VIVEVE IVIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

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What is being tested

Active Treatment Viveve

+ Sham Treatment Viveve

Device
Who is being recruted

From 18 to 65 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2015
See protocol details

Summary

Principal SponsorViveve Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleVIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
NCT02261974
Principal SponsorViveve Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

186 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

21 exclusion criteria prevent from participating
Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months.
Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment
History of a genital fistula, a thin recto-vaginal septum as determined by the investigator, or history of a fourth degree laceration during screening physical exam
Clinically significant pelvic organ prolapse
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus

Group II

Placebo
Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Suspended

Allan Centre

Calgary, CanadaOpen Allan Centre in Google Maps
Suspended

Complexe Medical St-Laurent

Montreal, Canada
Suspended

Les Cours Medical Centre

Montreal, Canada
Suspended

Exogenia Institute of Anti-Aging and Regenerative Medicine

Sherbrooke, Canada
Completed9 Study Centers