RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity (NCT04210583) | Clinical Trial Compass
CompletedNot Applicable
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Canada10 participantsStarted 2019-09-04
Plain-language summary
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.
Who can participate
Age range30 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. Subjects who have completed at least two treatments in the Venus Fiore™ CS0716 study and are at least 6 months post Fiore™ treatment.
✓. Able to read, understand and voluntarily provide written Informed Consent.
✓. Able and willing to comply with the treatment/follow-up schedule and requirements.
✓. Sexual active and in a monogamous relationship
Exclusion criteria
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treatment area.
✕. Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treatment areaduring the course of the study.
✕. Use of retinoids such as oral Isotretinoin (Accutane®) during the course of the study.
✕. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
What they're measuring
1
Long term safety (Follow-up for any AEs) of the Venus Fiore Fioreâ„¢ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia.