Voll Degradable Shoulder Spacer FIH Study
ConditionMassive Rotator Cuff Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorVoll Medical Technologies Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Voll Degradable Shoulder Spacer
DeviceVoll Degradable Shoulder Spacer
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Voll Degradable Shoulder SpacerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device-related Serious Adverse Events
Incidence of device-related serious adverse events (DRSAEs) related to the spacer.
Time frame
Up to 12 months post-implantationץSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov