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NCT02747641 · ClinicalTrials.gov registry record · NA

Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

A NA study of Vaginal Atrophy and Atrophy, sponsored by Alma Lasers.

Completed
Registry status
NA
Development phase
15
Enrollment target
1
Study location

NCT02747641 is a NA study of Vaginal Atrophy and Atrophy that has completed, run by Alma Lasers. The registered enrollment target is 15 participants, below the 355-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02747641, a NA study of Vaginal Atrophy and Atrophy, has completed, sponsored by Alma Lasers.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.

Interventions

  • PROCEDURE Pixel CO2 Laser System

Study Locations (1)

Florida

  • The Cleveland Clinic - Weston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2016-05
Est. Completion 2017-08
Phase NA

Sponsor

Alma Lasers

7 total trials

What the Registry Record Tells You About NCT02747641

The ClinicalTrials.gov registry entry for NCT02747641 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 355-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (96% lower). The listed sponsor is Alma Lasers, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Vaginal Atrophy appearing as the primary indexed condition, and to 1 intervention - of which Pixel CO2 Laser System is the first listed.

NCT02747641 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT02747641 about?

NCT02747641 is a clinical study titled "Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects". The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index i...

What is the current status of trial NCT02747641?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2016-05. Estimated completion is 2017-08.

What conditions does trial NCT02747641 study?

This clinical trial studies the following conditions: Vaginal Atrophy, Atrophy, Genital Diseases, Female.

What interventions are being tested in trial NCT02747641?

The interventions under investigation include: Pixel CO2 Laser System (PROCEDURE).

Who is sponsoring clinical trial NCT02747641?

This trial is sponsored by Alma Lasers, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02747641 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.