Voll Non-Degradable Shoulder Spacer FIH Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorVoll Medical Technologies Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
Concurrent participation in any other investigational clinical study.
Trial design
Treatments tested in this trial
- Voll Non-Degradable Shoulder Spacer
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov