Voll Degradable Shoulder Spacer FIH Study

Voll Medical Technologies Ltd.

Status: Enrolling

Conditions: Massive Rotator Cuff Tear

Treatments: Device: Voll Degradable Shoulder Spacer

Study type: Interventional

Funder types: Industry

Identifiers

NCT07208448

053CLD

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Voll Degradable Shoulder Spacer

Experimental group

Treatment:

Device: Voll Degradable Shoulder Spacer