Voll fully degradable shoulder spacer for massive rotator cuff tears
Official title: 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
Run by Voll Medical Technologies Ltd. · NCT07208448 · Data updated 2026-11-12
This will try a fully degradable shoulder spacer in people aged 50 and older with symptomatic massive rotator cuff tears to see if it is safe and helps shoulder pain and function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Voll Medical Technologies Ltd. Industry-sponsored |
| Locations | 4 sites (Ashdod and 3 other locations) |
| Status | Recruiting |
| Started | December 9, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07208448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 50 or older with symptomatic full‑thickness massive rotator cuff tears who are in generally good health and able to attend postoperative follow‑up visits.
✕Probably not a fit
Patients with a documented history of drug or alcohol abuse within the past year, those enrolled in other investigational studies, people medically unfit for surgery, or those with smaller or different shoulder pathologies are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first‑in‑human, interventional study of a fully degradable subacromial shoulder spacer implanted in patients with symptomatic full‑thickness massive rotator cuff tears. The device is placed surgically to create a temporary mechanical buffer in the subacromial space, with follow‑up visits to monitor safety, device degradation, and clinical outcomes such as pain and shoulder function. Eligible patients are adults aged 50 or older in generally good health who can comply with postoperative follow‑up; key exclusions include recent drug or alcohol abuse and participation in other investigational studies. The trial is being conducted at sites in Israel and Italy and will collect perioperative and serial clinical outcome data to characterize early safety and performance.
Why it matters
Potential benefit: If successful, the degradable spacer could reduce pain and improve shoulder function for patients with MRCT while avoiding a permanent implant or more invasive reconstruction.
How similar studies have gone: Biodegradable subacromial spacers have been tested before with mixed results, and this device represents a first‑in‑human test of Voll's specific degradable spacer design.
Who can join: the full rules
Show full inclusion / exclusion 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 of enrollment. * Concurrent participation in any other investigational clinical study.
Where it's running
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Assuta Ashdod Hospital
Ashdod, Israel Recruiting -
Humanitas Gavazzeni Castelli
Bergamo, Bergamo, Italy Recruiting -
Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy Recruiting -
Ichilov (Sourasky Medical Center)
Tel Aviv, Israel Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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Biceps Transposition Without Tenotomy to Augment Massive Rotator Cuff Repairs
This study tests whether moving the long head of the biceps tendon without cutting it helps improve shoulder function after partial rotator cuff repair in adults with large tears.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.