RecruitingNot ApplicableNCT07208448
Voll Degradable Shoulder Spacer FIH Study
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
Sponsor
Voll Medical Technologies Ltd.
Enrollment
20 participants
Start Date
Dec 9, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 50 Years
Inclusion Criteria2
- Full thickness MRCT.
- Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits.
Exclusion Criteria2
- Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- Concurrent participation in any other investigational clinical study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEVoll Degradable Shoulder Spacer
Voll Degradable Shoulder Spacer
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07208448