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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03366194
Eligibility Criteria:
Inclusion Criteria:
1. at least 23 years old
2. shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
3. The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.
Exclusion Criteria:
1. Pregnancy or chance of pregnancy
2. Currently taking Coumadin/Warfarin® or heparin
3. Diagnosis of any type of bleeding disorder
4. Any history of keloid formation
5. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
6. Diagnosis of mental disorders requiring inpatient treatment
7. Presence of metal implants around the proposed treatment areas
8. Diagnosis of any undefined wasting disease (Cachexia for example)
9. Diagnosis of an active infection in the treatment area other than mild acne
10. Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
11. Diagnosis of severe cardiovascular and cerebrovascular disease
12. Diagnosis of renal failure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
23 Years
Study:
NCT03366194
Study Brief:
Protocol Section:
NCT03366194