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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT03914703
Eligibility Criteria:
Inclusion Criteria
* EZ Pass Suture Passer:
\- Intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue.
* Precision Flexible Reamer:
* This device is a hand held, or hand-manipulated device, intended to be used in ACL and PCL reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries.
Exclusion Criteria
* EZ Pass Suture Passer:
\- Any use other than the approved uses indicated in the Instructions for Use (IFU).
* Precision Flexible Reamer:
* Any use other than the approved uses indicated in the Instructions for Use (IFU).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03914703
Study Brief:
Protocol Section:
NCT03914703