RecruitingNot Applicable

Voll Degradable Shoulder Spacer FIH Study

Israel, Italy20 participantsStarted 2025-12-09

Plain-language 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).

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Device-related Serious Adverse Events

Timeframe: Up to 12 months post-implantationץ

Trial details

NCT IDNCT07208448

SponsorVoll Medical Technologies Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Massive Rotator Cuff Tear trials