NCT07208448RecruitingNot Applicable
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
Voll Medical Technologies Ltd.4 sites in 2 countries20 target enrollmentStarted: December 9, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Device-related Serious Adverse Events
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •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 Criteria
- •Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- •Concurrent participation in any other investigational clinical study.
Arms & Interventions
Voll Degradable Shoulder Spacer
Experimental
Intervention: Voll Degradable Shoulder Spacer (Device)
Outcomes
Primary Outcomes
Device-related Serious Adverse Events
Time Frame: Up to 12 months post-implantationץ
Incidence of device-related serious adverse events (DRSAEs) related to the spacer.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
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