Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04511260
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT04511260
Study Brief:
Protocol Section:
NCT04511260