Voll Non-Degradable Shoulder Spacer FIH Study | NCT07745647

NCT07745647

Overview

NCT ID: NCT07745647
Lead Sponsor: Voll Medical Technologies Ltd.INDUSTRY
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
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).
Conditions: Massive Rotator Cuff Tears
Massive Rotator Cuff Tear
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

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