Voll Non-Degradable Shoulder Spacer FIH Study

A Single-Center, Prospective, First-In-Human Study to Evaluate the Initial Safety and Effectiveness of a Non-Degradable Shoulder Spacer in Patients With Symptomatic Massive Rotator Cuff Tears

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07745647

Enrollment

Registered

2026-08-04

Start date

2026-09-01

Completion date

2028-09-01

Last updated

2026-08-04

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

Conditions

Massive Rotator Cuff Tear, Massive Rotator Cuff Tears

Brief summary

The Voll Non-Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a non-degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).

Interventions

DEVICEVoll Non-Degradable Shoulder Spacer

Voll Non-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

* 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.

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-implantation	Incidence of device-related serious adverse events (DRSAEs) related to the spacer.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026