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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

Primary Purpose

Atrophy, Vaginal Atrophy, Genital Diseases, Female

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pixel CO2 Laser System
Sponsored by
Alma Lasers Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment

Arm Description

only one arm

Outcomes

Primary Outcome Measures

Vulvovaginal Atrophy (VVA)
Utilizing Bachman Vaginal Health Index

Secondary Outcome Measures

Full Information

First Posted
April 12, 2016
Last Updated
November 17, 2017
Sponsor
Alma Lasers Inc.
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02747641
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alma Lasers Inc.
Collaborators
The Cleveland Clinic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy, Vaginal Atrophy, Genital Diseases, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Other
Arm Description
only one arm
Intervention Type
Procedure
Intervention Name(s)
Pixel CO2 Laser System
Other Intervention Name(s)
FemiLift
Primary Outcome Measure Information:
Title
Vulvovaginal Atrophy (VVA)
Description
Utilizing Bachman Vaginal Health Index
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Cleveland Clinic
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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