Status:
UNKNOWN
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Lead Sponsor:
Lumenis Be Ltd.
Conditions:
Vagina Atrophy
Eligibility:
FEMALE
35-60 years
Phase:
NA
Brief Summary
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
Detailed Description
The treatment will include: A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04511260
Start Date
October 16 2020
End Date
June 20 2021
Last Update
December 8 2020
Active Locations (1)
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1
NYDerm
New York, New York, United States, 10028