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Fractional CO2 Laser

all subjects for Vulvovaginal Atrophy

N/A
Waitlist Available
Research Sponsored by Syneron Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks and 1 , 2 , 3, 5, 8, and 14 months
Awards & highlights

Study Summary

The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321 for dermatologic procedures requiring ablation and coagulation of soft tissues, including the skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol. Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks). Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit at the clinic.

Eligible Conditions
  • Vulvovaginal Atrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks and 1 , 2 , 3, 5, 8, and 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks and 1 , 2 , 3, 5, 8, and 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Vulvovaginal Symptom Questionnaire
Secondary outcome measures
Change from Baseline in Female Sex Function Index
Number of participants with adverse events
Satisfaction questionnaire
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: all subjectsExperimental Treatment1 Intervention
Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol. Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks). Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit at the clinic.

Find a Location

Who is running the clinical trial?

Syneron MedicalLead Sponsor
41 Previous Clinical Trials
1,672 Total Patients Enrolled
Konika Patel Schallen, MDStudy DirectorSyneron Candela
2 Previous Clinical Trials
32 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
2015. "Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02704741.
All > Vaginal Atrophy
~6 spots leftby May 2025
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