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:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT04176068
Eligibility Criteria:
Inclusion Criteria:
1. Exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician.
2. Subjects between the ages of 18-85 years old, at the time of consent.
3. Subjects may be male or female.
4. Subjects can be of any Fitzpatrick Skin type (I-VI).
5. Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand.
Exclusion Criteria:
1. Children and adolescents (less than 18 years old).
2. Subjects who are not willing or able to provide written consent.
3. Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
4. Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
5. Subjects with known blood coagulopathies.
6. Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the lower thigh such as lupus, morphea, sarcoid or mixed connective tissue disease).
7. Subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks.
8. Subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks.
9. Subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product.
10. Subjects with open wounds in the area of ultrasound treatment.
11. Subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment.
12. Female patients who are planning a pregnancy, currently pregnant or nursing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04176068
Study Brief:
Protocol Section:
NCT04176068