Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

Vaginal Atrophy Clinical Trial

Official title:

Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747641
• Other study ID #: FLA 15-110
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: November 17, 2017
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2016
• Source: Alma Lasers Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy, non-smoking

• Woman, age 35 to 70 yrs, menopausal

• Provided written Informed Consent

• Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.)

• Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system

• Normal PAP smear (up to 1 year prior to baseline)

• Vaginal canal, introitus and vestibule free of injuries and bleeding

• 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:

• Severe prolapse (POP>= grade 3)

• Use of photosensitive drugs

• Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).

• Any serious disease, or chronic condition, that could interfere with the study compliance

• Acute or actively present within the last 2 months HPV/HSV

• Undiagnosed vaginal bleeding

• Urge or overflow incontinence

• Patients who are on antidepressants, or a-adrenergic and anticholinergic medications

• Patients with immune system diseases.

• Patients with allergic reaction to laser.

• Obese women (BMI >30)

• Patient unable to follow post-treatment instructions

• History of keloid formation

• Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment

• A history of thrombophlebitis

• A history of acute infections

• A history of heart failure

• Previously undergone reconstructive pelvic surgery

• Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months

• Any medical condition that in the investigators opinion would interfere with the patients participation in the study

Related Conditions & MeSH terms

• Atrophy
• Genital Diseases, Female
• Vaginal Atrophy

Intervention

Procedure:
• Pixel CO2 Laser System

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Alma Lasers Inc.	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vulvovaginal Atrophy (VVA)	Utilizing Bachman Vaginal Health Index	6 months