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 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT01273961
Eligibility Criteria:
Inclusion Criteria:
* Male or female 21 to 70 years old,
* For females, at least 9 months post-partum,
* Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
* For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
* Apparently healthy,
* Informed consent signed by the subject.
Exclusion Criteria:
* History of skin hypersensitivity,
* Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
* Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
* Suffering from hormonal imbalance which may affect weight or cellulite,
* Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
* The current or recent use (within the past 12 months) of isotretinoin,
* Pregnancy or breast feeding,
* Infectious diseases (such as HIV) present,
* Are a tobacco smoker,
* Insulin dependent diabetic subjects,
* Oxygen dependent subjects,
* Subjects with severe chronic illness, scleroderma, or lupus,
* Subjects with open sores or scars in the treatment region, or
* Subjects with ischemia in the treatment region.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01273961
Study Brief:
Protocol Section:
NCT01273961