Recruiting

CO2 Laser

Sponsor:

SHERRY Thomas

Code:

NCT03271944

Conditions

Vulvovaginal Atrophy

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

CO2 Laser Treatment

Study Details

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

Study ID

NCT03271944

Start date

Dec 29, 2016

Status verified date

Mar, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Subjects meeting the following inclusion criteria may participate:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single group 30 post menopause females.

Interventions

CO2 Laser Treatment

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

Primary outcome measure

  • Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA). [ Time Frame: 9 month ]

Central Contacts and Locations

Locations

The American Association of Female Pelvic Medicine Specialists, Inc.

Recruiting

Agoura Hills, California, United States, 91301

Contacts

Sherry Thomas, MD

818-991-0988drsherrythomas@yahoo.com

Sharan Dhaliwal

8189910988

Principal Investigator:

Sherry Thomas, MD

More Information

Sponsor

SHERRY Thomas

Last update posted

Mar 23, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SHERRY Thomas on 2018-03-23.