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JuggerKnot With Broadband PMCF Study
Sponsor: Riverpoint Medical
Summary
The purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the JuggerKnot device and meet existing EU regulatory requirements.
Official title: JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2023-11-30
Completion Date
2025-12-30
Last Updated
2025-08-17
Healthy Volunteers
No
Interventions
Juggerknot with Broadband tape
The JuggerKnot system is comprised of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue to bone fixation by bunching against the bone when deployed. The anchor sleeve material is polyester. Suture materials are ultra-high molecular weight polyethylene. The device has 510K FDA clearance.
Locations (1)
MedStar Health Research Institute
Hyattsville, Maryland, United States