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NCT Number: NCT07208448

Voll Degradable Shoulder Spacer FIH Study

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).

Recruiting

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Key information

Conditions

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Voll Degradable Shoulder Spacer

Device

Voll Degradable Shoulder Spacer

Primary outcomes

  1. Device-related Serious Adverse Events

    Time frame: Up to 12 months post-implantationץ

    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 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2025
Registry last updated
Jul 30, 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.

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