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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06797167
Eligibility Criteria:
Inclusion Criteria:
* Subjects Informed consent form (ICF) signed;
* Female aged 40-65 years;
* Atrophy and/or hypotrophy of labra majora requiring volume augmentation. Hypotrophy will be preoperatively staged in mild, moderate and severe considering both the adipose tissue and the cutaneous layer;
* Body Mass Index (BMI)\<32 Kg/m2;
* Willingness to follow all study procedures, including attending all site visits, tests and examinations.
Exclusion Criteria:
* Allergy or controindications to device components;
* Allergy or controindications to anesthetic components;
* Previous surgery on external genitalia;
* Infectious or inflammatory processes close to the area of the procedure;
* History of vulvar cancer (including vulvar squamous papillomas) and/or previous regional radiotherapy;
* Active local herpes simplex or herpes zoster infection;
* Active herpes zoster infection in other sites;
* Active skin allergy including local dermatitis;
* Chronic pathological skin condition;
* Active mycosis and others bacterial infections;
* Immune system illnesses/disease;
* Known hypersensitivity to cheloids;
* Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
* Problems with coagulation or anti-coagulating therapies in progress;
* Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin C), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;
* Known drug and/or alcohol abuse;
* Mental incapacity that precludes adequate understanding or cooperation;
* Pregnancy or breastfeeding;
* COVID-19 vaccination within two month prior to study inclusion;
* Participation in another investigational study within 1 month prior to study inclusion.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06797167
Study Brief:
Protocol Section:
NCT06797167