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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2RE | Device | The CO2RE system device is intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Vulvovaginal Symptom Questionnaire | Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms. | Baseline, 1 , 2 , 3, 5, 8, and 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number, severity and duration of adverse events following CO2 treatment | throughout study duration, day 0 up to 17 months |
| Vaginal Health Index Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konika Patel Schallen, MD | Syneron Candela | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FamWell.MD | Jacksonville | Florida | 32207 | United States | ||
| 6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25333211 | Background | Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16. | |
| 32329093 | Derived |
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Evaluation of vaginal wall conditions such as pH, elasticity, bleeding signs, secretion type and consistency and hydration.
| Baseline, 1 , 2 , 3, 5, 8, and 14 months |
| Change from Baseline in Female Sex Function Index | Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms | Baseline, 1 , 2 , 3, 5, 8, and 14 months |
| Satisfaction questionnaire | A questionnaire will be used to evaluate satisfaction with treatment outcome | 2 weeks and 1 , 2 , 3, 5, 8, and 14 months |
| Visual analog score for pain | Patients will complete a visual analog scale to report pain level associated with treatment | day 0, 4 weeks, 8 weeks |
| Louisville |
| Kentucky |
| 40205 |
| United States |
| Syneron-Candela Institute for Excellence | Wayland | Massachusetts | 01778 | United States |
| Dermatology and Laser Surgery Center of New York | New York | New York | 10028 | United States |
| Alexiades MR. Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy. Lasers Surg Med. 2021 Feb;53(2):185-198. doi: 10.1002/lsm.23247. Epub 2020 Apr 23. |