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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03863834
Eligibility Criteria:
Inclusion Criteria:
* Informed consent agreement signed by the subject.
* Healthy females 21 to 60 years of age.
* Presence of grade I-III Breast Ptosis, mastopexy with history of breast augmentation, correction of asymmetry, mastopexy alone, mastopexy following implant removal and modest breast reduction in combination with or without lipoaspiration.
* Post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
* Willingness to follow the treatment and follow-up schedule and the post-treatment care.
* All participants must have a recorded mammogram before the beginning of the study.
Exclusion Criteria:
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
* Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* History of bleeding coagulopathies or use of anticoagulants in the last 2 weeks.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* Significant systemic illness or occult systemic illness.
* Illness, infection or skin diseases localized in area of treatment.
* Other therapies or medication which may interfere with treatment.
* Breastfeeding, pregnant, or planning to become pregnant during the study.
* Allergy to lidocaine or other anaesthesia.
* Recent surgery in treatment area within the past 6 months.
* Participation in a study of another device or drug within 3 months prior to enrolment or during this study.
* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the patient to participate in this study.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT03863834
Study Brief:
Protocol Section:
NCT03863834