Status:
UNKNOWN
Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy
Lead Sponsor:
SHERRY Thomas
Collaborating Sponsors:
Perigree Medical
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
40-80 years
Phase:
NA
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03271944
Start Date
December 29 2016
End Date
December 1 2019
Last Update
March 23 2018
Active Locations (1)
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1
The American Association of Female Pelvic Medicine Specialists, Inc.
Agoura Hills, California, United States, 91301