Voll Non-Degradable Shoulder Spacer FIH Study

N/ANot Yet RecruitingNCT07745647

Voll Medical Technologies Ltd.10 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Massive Rotator Cuff Tears Massive Rotator Cuff Tear

Interventions

Voll Non-Degradable Shoulder SpacerDEVICE

Voll Non-Degradable Shoulder Spacer

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Assuta Ashdod Hospital

Ashdod, Israel

Outcomes

Primary Outcomes

Device-related Serious Adverse Events

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

Time frame: Up to 12 months post-implantation

Data from ClinicalTrials.gov

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