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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07208448

Enrollment

Registered

2025-10-06

Start date

2025-12-09

Completion date

2027-12-31

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massive Rotator Cuff Tear

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 symptomatic massive rotator cuff tears (MRCT).

Interventions

DEVICEVoll Degradable Shoulder Spacer

Voll Degradable Shoulder Spacer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Device-related Serious Adverse Events	Up to 12 months post-implantationץ	Incidence of device-related serious adverse events (DRSAEs) related to the spacer.

Countries

Israel, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026