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

NCT ID: NCT03271944

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-29
• Study Completion Date: 2019-12-31

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).

Detailed Description

The purpose of this study is to evaluate the use of a CO2 laser (EdgeTM CO2 Laser) with a fractional handpiece made specifically for the vagina to possibly restore the normal physiological conditions of the vagina, thus reducing the symptoms of VVA. The EdgeTM CO2 Laser and general fractional handpiece is approved by the FDA for ablative skin resurfacing (for example, treating fine lines and wrinkles, acne and surgical scars, skin pigmentation and discoloration, sun damage, pre-cancerous as well as benign lesions and uneven skin texture). The fractional handpiece used in this study for the treatment of VVA is experimental and has not been approved by the FDA for vaginal dryness associated with menopause.

Conditions

Vulvovaginal Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single group 30 post menopause females.

Group Type: OTHER

CO2 Laser Treatment

Intervention Type: DEVICE

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

Interventions

CO2 Laser Treatment

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Perigree Medical

UNKNOWN

Sponsor Role: collaborator

SHERRY Thomas

OTHER

Sponsor Role: lead

Responsible Party

SHERRY Thomas

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The American Association of Female Pelvic Medicine Specialists, Inc.

Agoura Hills, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Sherry Thomas, MD

Role: primary

drsherrythomas@yahoo.com

818-991-0988

Sharan Dhaliwal

Role: backup

8189910988

Other Identifiers

20161370

Identifier Type: -

Identifier Source: org_study_id