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NCT02770287 · ClinicalTrials.gov registry record · NA

Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus

A NA study, sponsored by Venus Concept.

Completed
Registry status
NA
Development phase
11
Enrollment target

NCT02770287: Completed NA study, sponsored by Venus Concept.

NCT02770287 is a NA study that has completed, run by Venus Concept. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02770287, a NA study, has completed, sponsored by Venus Concept.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target

Study Summary

The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons pubis and Labia, and will result in improvement in general skin appearance including an improvement in skin irregularities and skin laxity.

Primary Outcome

Improvement in general skin appearance at follow-up visit 3 as compared to baseline as assessed by independent blinded evaluator by photographic assessment, utilizing the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = much worse and -3 = very much worse where higher scores indicate a better outcome.

Interventions

  • DEVICE Venus Freeze Diamond Polar

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2016-03-26
Est. Completion 2017-11-30
Phase NA
Venus Concept

22 total trials

What the finished NCT02770287 record still lists

NCT02770287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Venus Freeze Diamond Polar is the first listed.

NCT02770287 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02770287 about?

NCT02770287 is a clinical study titled "Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus". The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons pubis and Labia, and will result in improvement in general skin appearance including an improvement in skin irregularities and skin laxity.

What is the current status of trial NCT02770287?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2016-03-26. Estimated completion is 2017-11-30.

What interventions are being tested in trial NCT02770287?

The interventions under investigation include: Venus Freeze Diamond Polar (DEVICE).

Who is sponsoring clinical trial NCT02770287?

This trial is sponsored by Venus Concept, which has 22 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02770287's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02770287, the US trial registry maintained by the National Library of Medicine. NCT02770287 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.