Clinical Trials in Italy / NCT07208448
Recruiting
Not applicable
Voll Degradable Shoulder Spacer FIH Study
NCT07208448 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Massive Rotator Cuff Tear
Investigational drug(s) / intervention(s)
Voll Degradable Shoulder Spacer
Voll Degradable Shoulder Spacer: Voll Degradable Shoulder Spacer
Study 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
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 of enrollment.
* Concurrent participation in any other investigational clinical study.
Primary outcome measure(s)
- Device-related Serious Adverse Events — Up to 12 months post-implantationץ
Incidence of device-related serious adverse events (DRSAEs) related to the spacer.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Assuta Ashdod Hospital | Ashdod | Israel | Recruiting |
| Ichilov (Sourasky Medical Center) | Tel Aviv | Israel | Not Yet Recruiting |
| Humanitas Gavazzeni Castelli | Bergamo | Bergamo | Recruiting |
| Istituto Ortopedico Rizzoli | Bologna | Bologna | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07208448 on ClinicalTrials.gov ↗ ← All trials in Italy