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Voll Degradable Shoulder Spacer FIH Study
Sponsor: Voll Medical Technologies Ltd.
Summary
The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).
Official title: A Multi-Center, Prospective, First-In-Human Study to Evaluate the Initial Safety and Effectiveness of a Degradable Shoulder Spacer in Patients With Symptomatic Massive Rotator Cuff Tears
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-12-09
Completion Date
2027-12-31
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Voll Degradable Shoulder Spacer
Voll Degradable Shoulder Spacer
Locations (4)
Assuta Ashdod Hospital
Ashdod, Israel
Ichilov (Sourasky Medical Center)
Tel Aviv, Israel
Humanitas Gavazzeni Castelli
Bergamo, Bergamo, Italy
Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy