Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

NCT03271944 | Unknown DMC FDA Device

• 1 other identifier: 20161370
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm VAS).

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA).

  The purpose of this study is to evaluate efficacy and safety of CO2 laser (EdgeTM CO2 Laser) with a fractional headpiece in the treatment of vulvovaginal atrophy (VVA) in post- menopausal women and its effect on the patient VHIS (vaginal health index score). The primary endpoint is to assess the changes in the vaginal dryness by mean of a visual analog scale (10 cm VAS).

  9 month

Study Arms (1)

Single group 30 post menopause females.

OTHER

Device: CO2 Laser Treatment

Interventions

CO2 Laser Treatment DEVICE

Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy

Single group 30 post menopause females.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
• Exhibiting VVA symptoms
• Prolapse staged \< II, according to the pelvic organ prolapse quantification (ICS-POP- Q) system
• Have not had procedures in the anatomical area through 6 months prior to treatment
• Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from participation:
• Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
• Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP- Q) system
• Any serious disease, or chronic condition, that could interfere with the study compliance
• Previously undergone reconstructive pelvic surgery
• Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
• A history of thrombophlebitis
• A history of acute infections
• A history of heart failure
• Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
• Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
• Taking medications that are photosensitive
• A history of keloid formation

Sponsors & Collaborators

• SHERRY Thomas: lead
• Perigree Medical: collaborator

Study Sites (1)

The American Association of Female Pelvic Medicine Specialists, Inc.

Agoura Hills, California, 91301, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: December 29, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (1)