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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Vaginal Atrophy

Intervention / Treatment
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* Device: CO2RE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects seeking treatment of Vaginal Atrophy in the vagina area (External - vestibule and introitus; Internal - Vaginal canal) Healthy female subjects age greater than or equal to 35 years of age who are post menopausal for at least one year, for any reason whether surgical , chemical or natural. Absence of menstruation for at least 12 months Not responding to or satisfied with previous local estrogen therapy Desire to maintain sexual activity Informed consent process completed and subject signed consent Willing to receive the proposed CO2RE treatment and follow-up protocol Post-menopausal or surgically sterilized. Normal cell cytology (PAP smear) Negative urinalysis and a normal vaginal canal (no evidence of dysplasia and occult or active infection) The external vaginal area (vestibule and introitus) free of injuries and bleeding Subject experienced sexual activity at least once a month Exclusion Criteria: Subject had surgery or any other procedure for Vaginal Tightening in the last 12 months Use of hormone replacement therapy, either systemic or local within the last 6 months prior to study Lubricants or any localized preparation in the 30 days prior to enrollment Patient with history of herpes. Acute or recurrent urinary tract infection (UTI) or genital infection (e.g. herpes, candida) Active malignancy or history of malignancy in the past 5 years Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the treatment, or healing process) Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion) History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen History of significant lymphatic drainage problems History of cancer which required lymph node biopsy or dissection Suffering from significant conditions in the treated areas or inflammatory conditions, including, but not limited to, open lacerations or abrasions of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course History of keloid scarring, abnormal wound healing and / or prone to bruising History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders Use of isotretinoin (Accutane®) within 6 months of treatment or during the study Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study Dysplastic nevi in the area to be treated Participation in a study of another device or drug within 6 month prior to enrollment or during this study, if treatments of vagina were involved As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study Prolapse staged >_ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system Previously undergone pelvic reconstructive surgery

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: all subjects<br>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. | Device: CO2RE<br>* The CO2RE system device is intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |