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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT03752034
Eligibility Criteria:
Inclusion Criteria:
* Males and females, ages 40 to 80 years
* Unilateral Disease
* \< 1.5cm tear
Exclusion Criteria:
* Diabetes
* Peripheral Neuropathy
* Previous Shoulder Surgery
* Pain Syndrome; cuff arthroplasty
* Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies
* Arthritis of Shoulder
* Unwilling or unable to comply with post-operative instructions or follow-up visits
* Auto Immune Disease
* Complete Subscapularis Tear
* Teres Minor involvement
* History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2
* Pregnancy
* Implanted devices containing ferromagnetic material
* Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator)
* Any other condition which the PI feels would be not in the best interest for the patient or the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03752034
Study Brief:
Protocol Section:
NCT03752034