MedTrace Logo

Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments

NCT02704741 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-06-14

No results posted yet for this study

Summary

The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321 for dermatologic procedures requiring ablation and coagulation of soft tissues, including the skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol.

Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks).

Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit at the clinic.

Conditions

  • Vaginal Atrophy

Interventions

DEVICE

CO2RE

The CO2RE system device is intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin

Sponsors & Collaborators

  • Syneron Medical

    lead INDUSTRY

Principal Investigators

  • Konika Patel Schallen, MD · Syneron Candela

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02704741 on ClinicalTrials.gov