LIBERATE International

Status Completed

Clinical Trial Summary

This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.

Clinical Trial Description

Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03619174
Study type	Interventional
Source	Viveve Inc.
Contact
Status	Completed
Phase	N/A
Start date	August 8, 2018
Completion date	July 5, 2019

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