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

June 12, 2018 updated by: Syneron Medical

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Jacksonville, Florida, United States, 32207
        • FamWell.MD
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • 6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US
    • Massachusetts
      • Wayland, Massachusetts, United States, 01778
        • Syneron-Candela Institute for Excellence
    • New York
      • New York, New York, United States, 10028
        • Dermatology and Laser Surgery Center of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects seeking treatment of Vaginal Atrophy in the vagina area (External - vestibule and introitus; Internal - Vaginal canal)
  2. 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.
  3. Absence of menstruation for at least 12 months
  4. Not responding to or satisfied with previous local estrogen therapy
  5. Desire to maintain sexual activity
  6. Informed consent process completed and subject signed consent
  7. Willing to receive the proposed CO2RE treatment and follow-up protocol
  8. Post-menopausal or surgically sterilized.
  9. Normal cell cytology (PAP smear)
  10. Negative urinalysis and a normal vaginal canal (no evidence of dysplasia and occult or active infection)
  11. The external vaginal area (vestibule and introitus) free of injuries and bleeding
  12. Subject experienced sexual activity at least once a month

Exclusion Criteria:

  1. Subject had surgery or any other procedure for Vaginal Tightening in the last 12 months
  2. Use of hormone replacement therapy, either systemic or local within the last 6 months prior to study
  3. Lubricants or any localized preparation in the 30 days prior to enrollment
  4. Patient with history of herpes.
  5. Acute or recurrent urinary tract infection (UTI) or genital infection (e.g. herpes, candida)
  6. Active malignancy or history of malignancy in the past 5 years
  7. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
  8. 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)
  9. 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)
  10. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
  11. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
  12. History of significant lymphatic drainage problems
  13. History of cancer which required lymph node biopsy or dissection
  14. 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
  15. History of keloid scarring, abnormal wound healing and / or prone to bruising
  16. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
  17. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
  18. Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
  19. Dysplastic nevi in the area to be treated
  20. 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
  21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
  22. Prolapse staged >_ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
  23. Previously undergone pelvic reconstructive surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: all subjects

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Vulvovaginal Symptom Questionnaire
Time Frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
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
Time Frame: throughout study duration, day 0 up to 17 months
Number, severity and duration of adverse events following CO2 treatment
throughout study duration, day 0 up to 17 months
Vaginal Health Index Improvement
Time Frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
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
Time Frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
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
Time Frame: 2 weeks and 1 , 2 , 3, 5, 8, and 14 months
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
Time Frame: day 0, 4 weeks, 8 weeks
Patients will complete a visual analog scale to report pain level associated with treatment
day 0, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Konika Patel Schallen, MD, Syneron Candela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHF19731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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