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Trial record 2 of 4 for:    sherry thomas

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

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ClinicalTrials.gov Identifier: NCT03271944
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Perigree Medical
Information provided by (Responsible Party):
SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc.

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).

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Device: CO2 Laser Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy
Actual Study Start Date : December 29, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single group 30 post menopause females. Device: CO2 Laser Treatment
Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy




Primary Outcome Measures :
  1. Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA). [ Time Frame: 9 month ]
    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).



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271944


Locations
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United States, California
The American Association of Female Pelvic Medicine Specialists, Inc. Recruiting
Agoura Hills, California, United States, 91301
Contact: Sherry Thomas, MD    818-991-0988    drsherrythomas@yahoo.com   
Contact: Sharan Dhaliwal    8189910988      
Principal Investigator: Sherry Thomas, MD         
Sponsors and Collaborators
SHERRY Thomas
Perigree Medical

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Responsible Party: SHERRY Thomas, Principal Investigator, The American Association of Female Pelvic Medicine Specialists, Inc.
ClinicalTrials.gov Identifier: NCT03271944     History of Changes
Other Study ID Numbers: 20161370
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical