Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548882
Status:
WITHDRAWN
Last Update Posted:
2021-11-08
First Post:
2020-09-08
Brief Title:
Calypso Knee System Clinical Sub-study OUS Continued Evaluation
Sponsor:
Moximed
Organization:
Moximed
Study Overview
Official Title:
Continued Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis OUS
Status:
WITHDRAWN
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed based on continued restrictions around COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Calypso Knee System Clinical Study OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System
Detailed Description:
This sub-study will be a single-arm prospective multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None