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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT06353893
Eligibility Criteria:
Inclusion Criteria:
* Rotator cuff tear (both partial and full thickness) treated with Integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row);
* Subject can read and understand the ICF and has voluntarily provided written informed consent.
Exclusion Criteria:
* Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions;
* If patient is pregnant;
* Subject conditions which may hinder the healing process;
* Subject is a prisoner or member of another vulnerable population.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06353893
Study Brief:
Protocol Section:
NCT06353893