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Active, not recruiting Not applicable Interventional

Episealer® Knee System IDE Clinical Study

NCT04000659
Conditions
Degenerative Lesion of Articular Cartilage of Knee
Interventions
Episealer Knee System, Microfracture
Device · Procedure
Lead sponsor
Episurf Medical Inc.
Industry
Eligibility
30 Years to 70 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2028
U.S. locations
8
States / cities
Tempe, Arizona • La Mesa, California • New Orleans, Louisiana + 5 more
Conditions
Knee Injuries, Cartilage Injury, Cartilage Disease, Knee Discomfort
Interventions
Microfracture, Microfracture plus placement of Chondro-Gide® ACC
Procedure · Device
Lead sponsor
Geistlich Pharma AG
Industry
Eligibility
18 Years to 55 Years
Enrollment
82 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
3
States / cities
Phoenix, Arizona • Stamford, Connecticut • Johns Creek, Georgia
Conditions
Articular Cartilage Defects in the Knee Joint
Interventions
GelrinC, Microfracture historical control arm
Device · Other
Lead sponsor
Regentis Biomaterials
Industry
Eligibility
18 Years to 50 Years
Enrollment
181 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
13
States / cities
La Mesa, California • Orange, California • Denver, Colorado + 10 more
Conditions
Chondral Lesion Plus Partial Medial Meniscectomy
Interventions
Mechanical Debridement, RF-Based Debridement
Device
Lead sponsor
Smith & Nephew, Inc.
Industry
Eligibility
18 Years and older
Enrollment
148 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
7
States / cities
Tucson, Arizona • Gulf Breeze, Florida • Greenwood, Indiana + 4 more
Conditions
Chondral Lesion of the Knee, Meniscal Injuries, Cartilage Defects of the Knee, Osteoarthritis (OA) of the Knee
Interventions
Bone Marrow Aspirate (BMA), Arthroscopic Debridement Surgery, Saline
Biological · Procedure · Other
Lead sponsor
Hospital for Special Surgery, New York
Other
Eligibility
18 Years to 64 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
New York, New York