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Trial record 2 of 6 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 : Unknown
Verified March 2018 by SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc..
Recruitment status was:  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.

Tracking Information
First Submitted Date  ICMJE August 29, 2017
First Posted Date  ICMJE September 5, 2017
Last Update Posted Date March 23, 2018
Actual Study Start Date  ICMJE December 29, 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy
Official Title  ICMJE Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Atrophy
Intervention  ICMJE Device: CO2 Laser Treatment
Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy
Study Arms  ICMJE Single group 30 post menopause females.
Intervention: Device: CO2 Laser Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 1, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03271944
Other Study ID Numbers  ICMJE 20161370
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc.
Study Sponsor  ICMJE SHERRY Thomas
Collaborators  ICMJE Perigree Medical
Investigators  ICMJE Not Provided
PRS Account The American Association of Female Pelvic Medicine Specialists, Inc.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP