InSpace™ System Implantation in a Procedure Under Local Anesthesia
NCT02208453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2019-08-28
Summary
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
Conditions
- Rotator Cuff Tear
Interventions
- DEVICE
-
InSpace Implantation
InSpace device Implantation
Sponsors & Collaborators
-
OrthoSpace Ltd.
lead INDUSTRY
Principal Investigators
-
Enrico Gervasi, MD · Orthopedic Department, Latisana Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2018-06-30
- Completion
- 2019-04-30
Countries
- Italy
Study Locations
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