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

NCT02704741 | Unknown

• 1 other identifier: DHF19731
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of participants with adverse events

  throughout study duration, day 0 up to 17 months

• Vaginal Health Index Improvement

  Baseline, 1 , 2 , 3, 5, 8, and 14 months

• Change from Baseline in Female Sex Function Index

  Baseline, 1 , 2 , 3, 5, 8, and 14 months

• Satisfaction questionnaire

  2 weeks and 1 , 2 , 3, 5, 8, and 14 months

• Visual analog score for pain

  day 0, 4 weeks, 8 weeks

Study Arms (1)

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.

Device: CO2RE

Interventions

CO2RE DEVICE

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

all subjects

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (4)

FamWell.MD

Jacksonville, Florida, 32207, United States

Location

6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US

Louisville, Kentucky, 40205, United States

Location

Syneron-Candela Institute for Excellence

Wayland, Massachusetts, 01778, United States

Location

Dermatology and Laser Surgery Center of New York

New York, New York, 10028, United States

Location

Related Publications (2)

• 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.

  PMID: 25333211 BACKGROUND

• 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.

  PMID: 32329093 DERIVED

Study Officials

• Konika Patel Schallen, MD

  Syneron Candela

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 10, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (4)