NCT02704741

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Vaginal Atrophy

Interventions

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

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-06-01
• Completion: 2019-09-01
• First posted: 2016-03-10
• Last updated: 2018-06-14

Locations

4 sites across 1 country: United States