Voll Degradable Shoulder Spacer FIH Study
Recruiting
N/A
Interventional Study
Massive Rotator Cuff Tear
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Voll Medical Technologies Ltd. · Industry
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About This Trial
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).
Trial Locations
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Eligibility 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.
Main Exclusion Criteria:
* Documented evidence of a history of drug/alcohol abuse within 1 year …
Contacts
No contact information available.