Voll Non-Degradable Shoulder Spacer FIH Study

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).

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Key information

Conditions

Massive Rotator Cuff Tears Massive Rotator Cuff Tear

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod Hospital

Ashdod, Israel

Location contact

Ran Atzmon, MD

PRINCIPAL_INVESTIGATOR

Sahar Boostenay

CONTACT

[email protected]

+972544621243

Yariv Goldstein, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voll Non-Degradable Shoulder Spacer

Device

Voll Non-Degradable Shoulder Spacer

Primary outcomes

Device-related Serious Adverse Events

Time frame: Up to 12 months post-implantation

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

Sponsors and collaborators

Lead sponsor

Voll Medical Technologies Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Aug 4, 2026
Registry last updated: Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting