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

November 17, 2017 updated by: Alma Lasers Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: treatment
only one arm
Procedure: Pixel CO2 Laser System
Other Names:
  • FemiLift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvovaginal Atrophy (VVA)
Time Frame: 6 months
Utilizing Bachman Vaginal Health Index
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alma Lasers Inc.

Collaborators

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLA 15-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrophy

Clinical Trials on Pixel CO2 Laser System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe