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Status unknownNCT03271944Updated Mar 23, 2018

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

An interventional study of CO2 Laser Treatment in Vulvovaginal Atrophy, sponsored by SHERRY Thomas. Status unknown at 1 site in United States. Open to female participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by SHERRY Thomas · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Vulvovaginal Atrophy
03

In context

Lead sponsor

SHERRY Thomas is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Single group 30 post menopause females.

    Device: CO2 Laser Treatment

Interventions

  • DeviceCO2 Laser Treatment

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 9 month

07

Study locations

1 of 1 sites recruiting
  • The American Association of Female Pelvic Medicine Specialists, Inc.
    Agoura Hills, California 91301, United States
    Recruiting
    • Sherry Thomas, MD · Contactdrsherrythomas@yahoo.com · 818-991-0988
    • Sharan Dhaliwal · Contact8189910988
    • Sherry Thomas, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2016 (actual). Primary completion is estimated for Dec 2018, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 5, 2017
StartActual
Dec 29, 2016
Primary completionEst.
Dec 2018
CompletionEst.
Dec 2019
Last update
Mar 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03271944
Lead sponsor
SHERRY Thomas
Collaborators
Perigree Medical
Responsible party
SHERRY Thomas (Principal Investigator, The American Association of Female Pelvic Medicine Specialists, Inc.) — Sponsor-investigator
First posted
Sep 5, 2017
Start date
Dec 29, 2016
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Mar 23, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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