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Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

Primary Purpose

Vulvovaginal Atrophy

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CO2 Laser Treatment

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

The American Association of Female Pelvic Medicine Specialists, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single group 30 post menopause females.

Arm Description

Outcomes

Primary Outcome Measures

Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA).

The purpose of this study is to evaluate efficacy and safety of CO2 laser (EdgeTM CO2 Laser) with a fractional headpiece in the treatment of vulvovaginal atrophy (VVA) in post- menopausal women and its effect on the patient VHIS (vaginal health index score). The primary endpoint is to assess the changes in the vaginal dryness by mean of a visual analog scale (10 cm VAS).

Secondary Outcome Measures

Full Information

NCT ID

NCT03271944

First Posted

August 29, 2017

Last Updated

March 22, 2018

Sponsor

SHERRY Thomas

Collaborators

Perigree Medical

1. Study Identification

Unique Protocol Identification Number

NCT03271944

Brief Title

Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

Official Title

Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 29, 2016 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

SHERRY Thomas

Collaborators

Perigree Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

The purpose of this study is to evaluate the use of a CO2 laser (EdgeTM CO2 Laser) with a fractional handpiece made specifically for the vagina to possibly restore the normal physiological conditions of the vagina, thus reducing the symptoms of VVA. The EdgeTM CO2 Laser and general fractional handpiece is approved by the FDA for ablative skin resurfacing (for example, treating fine lines and wrinkles, acne and surgical scars, skin pigmentation and discoloration, sun damage, pre-cancerous as well as benign lesions and uneven skin texture). The fractional handpiece used in this study for the treatment of VVA is experimental and has not been approved by the FDA for vaginal dryness associated with menopause.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single group 30 post menopause females.

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

CO2 Laser Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA).

Description

Time Frame

9 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

The American Association of Female Pelvic Medicine Specialists, Inc.

City

Agoura Hills

State/Province

California

ZIP/Postal Code

91301

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherry Thomas, MD

Phone

818-991-0988

drsherrythomas@yahoo.com

First Name & Middle Initial & Last Name & Degree

Sharan Dhaliwal

Phone

8189910988

First Name & Middle Initial & Last Name & Degree

Sherry Thomas, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

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