Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
Public ClinicalTrials.gov record NCT02704741. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02704741
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2015 (Actual)
- Primary completion
- Jun 2019 (Estimated)
- Completion
- Sep 2019 (Estimated)
- Last update posted
- Jun 14, 2018
2015 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| FamWell.MD | Jacksonville | Florida | 32207 | — |
| 6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US | Louisville | Kentucky | 40205 | — |
| Syneron-Candela Institute for Excellence | Wayland | Massachusetts | 01778 | — |
| Dermatology and Laser Surgery Center of New York | New York | New York | 10028 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02704741, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2018 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02704741 live on ClinicalTrials.gov.