Vaginal Atrophy Clinical Trial
Official title:
Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
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.
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).
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