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Episealer® Knee System IDE Clinical Study

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NCT04000659

Sponsored by Episurf Medical Inc. (industry) · EPIS-B.ST — their whole pipeline →. With MCRA.

Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
13actual
Sites
13
Countries
Canada, Germany, United Kingdom +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-06-18actualWhen the study began enrolling
Primary completionJun 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionJun 2028estimatedThe whole study's end, after follow-up
First posted2019-06-27actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2024-07-30actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Degenerative Lesion of Articular Cartilage of Knee

Interventions

  • Device: Episealer Knee System
  • Procedure: Microfracture

Primary outcomes

what the primary-completion date above is the date OF
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
measured 24 Months
Change in Visual Analog Scale (VAS) Pain Scores
measured 24 Months
Incidence of Secondary Surgical Intervention
measured 24 Months
Incidence of subsidence or migration at 24 months
measured 24 Months
Weight bearing status
measured 8 weeks

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