Status:
NOT_YET_RECRUITING
Voll Degradable Shoulder Spacer FIH Study
Lead Sponsor:
Voll Medical Technologies Ltd.
Conditions:
Massive Rotator Cuff Tear
Eligibility:
All Genders
50+ years
Phase:
NA
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 sy...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- Concurrent participation in any other investigational clinical study.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07208448
Start Date
October 15 2025
End Date
December 31 2027
Last Update
October 6 2025
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