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Not yet recruiting NCT07745647

Voll Non-Degradable Shoulder Spacer FIH Study

No phase Interventional Massive Rotator Cuff Tears Massive Rotator Cuff Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voll Non-Degradable Shoulder Spacer.
Who it may be relevant to
Registry conditions: Massive Rotator Cuff Tears, Massive Rotator Cuff Tear. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Device Voll Non-Degradable Shoulder Spacer
    Voll Non-Degradable Shoulder Spacer

Primary outcome measures

  • Device-related Serious Adverse Events [Time frame: Up to 12 months post-implantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Assuta Ashdod Hospital — Ashdod

Identifiers

NCT: NCT07745647 · 216CLD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗