NCT07208448

Voll Degradable Shoulder Spacer FIH Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Voll Medical Technologies Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Massive Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Voll Degradable Shoulder Spacer	Voll Degradable Shoulder Spacer

Timeline

• Start date: 2025-12-09
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-10-06
• Last updated: 2026-03-06

Locations

4 sites across 2 countries: Israel, Italy