Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity

Status unconfirmed · Not applicable

Conditions studied: Vagina Atrophy

In brief

Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.

Key facts

Study ID

NCT04511260

Run by

Lumenis Be Ltd.

People needed

20

Starts

2020-10-16

Expected to finish

2021-06-20

Last updated by the study team

2020-12-08

Who can join

Age: 35 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women age between 35 to 60
• Last vaginal delivery is at least 12 months prior to enrollment
• Self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the Vaginal Laxity Questionnaire (VLQ)
• Sexual activity≥ once per month, with a same partner
• Willing to use contraception for the duration of the study
• Negative urine analysis
• Negative pregnancy test
• Patient is not pregnant nor planning to become pregnant throughout the duration of the study
• Willing to improve vaginal lips / genitals appearance (optional)
• Normal gynecological exam from the recent year
• If taking probiotics and/or any other supplement or suppository as part of daily regimen, willing to maintain same regimen throughout the entire duration of the study
• Able and willing to comply with the treatment/follow-up schedule and requirements ·
• Willing to sign an informed consent

You may not qualify if…

• Previous pelvic floor reconstructive surgery with mesh.
• Pelvic organ prolapse (POP) >II according to the pelvic organ prolapse quantification system
• Pregnant or lactating
• Women in post-menopausal stage for more than five years.
• Active genital infection or sexually transmitted diseases
• Subject presenting abnormal Pap smear result from the last five years with any of the following findings according to the Bethesda System (2001) classification: A.. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion B. Atypical Glandular Cells (Endocervical, Endometrial not otherwise specified) C. High Grade squamous intraepithelial lesion (HSIL)D. Carcinoma
• Patients with implantable devices, such as but not limited to pacemakers, implanted defibrillators, and Cochlear ear implant
• Serious systemic disease or any chronic condition that could interfere with study compliance
• Has metal implant(s) within the treated area, such as surgical clips, plates and screws, intrauterine device (IUD) or artificial joints
• History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
• History of vaginal tissue disease in the treatment area
• Taken part in a clinical trial involving an investigational drug or device within 30 days prior to screening and through the study duration
• Presence of Vulvar lesions or any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
• Nerve insensitivity to heat anywhere in the treatment area, since ongoing feedback by a patient during a procedure is required
• Previous treatment with a vaginal energy based device, including laser treatment.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

Where it is running

• NYDerm — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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