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Clinical Trial 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.


Clinical Trial Description

This study is a Prospective clinical study to demonstrate the CO2RE laser device for safety and efficacy for Vaginal Atrophy.

Up to a total of 60 healthy candidates, seeking vaginal treatment from the participating investigator will be enrolled at a participating study site. Subjects will receive three (3) CO2RE treatments.

Each subject will be followed for additional 5 post treatment visits (FU visits) that will be conducted at:

- One week post first treatment - 1wk FU ± 2 days (Safety).

- 1 month post last treatment - 1m FU ± 2 weeks (efficacy & Safety).

- 3 months post last treatment - 3m FU ± 2 weeks (efficacy & Safety).

- 6 months post last treatment - 6m FU ± 2 weeks (efficacy & Safety).

- 12 months post last treatment - 12m FU ± 2 weeks (efficacy & Safety). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02704741
Study type Interventional
Source Syneron Medical
Contact
Status Active, not recruiting
Phase N/A
Start date September 2015
Completion date September 2019

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