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

NCT02747641 | Completed

• 1 other identifier: FLA 15-110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrophy; Vaginal Atrophy; Genital Diseases, Female

Outcome Measures

Primary Outcomes (1)

• Vulvovaginal Atrophy (VVA)

  Utilizing Bachman Vaginal Health Index

  6 months

Study Arms (1)

treatment

OTHER

only one arm

Procedure: Pixel CO2 Laser System

Interventions

Pixel CO2 Laser System PROCEDURE

Also known as: FemiLift

treatment

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 α-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

Sponsors & Collaborators

• Alma Lasers Inc.: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

The Cleveland Clinic

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Atrophy; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 22, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: November 21, 2017

Record last verified: 2016-10

Locations

US (1)