Massive Rotator Cuff TearsNCT07745647
Voll Non-Degradable Shoulder Spacer FIH Study
A study testing Voll Non-Degradable Shoulder Spacer in people with Massive Rotator Cuff Tears and Massive Rotator Cuff Tear, run by Voll Medical Technologies Ltd. at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
- What is being tested?
- Voll Non-Degradable Shoulder Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- Concurrent participation in any other investigational clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Assuta Ashdod Hospital
Ashdod
Sahar Boostenay, +972544621243, sahar@vollmedical.com
Ran Atzmon, MD
About this study
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
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).
- Being tested
- Voll Non-Degradable Shoulder Spacer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voll Non-Degradable Shoulder SpacerDevice
Voll Non-Degradable Shoulder Spacer
| Study group | Role | What they receive |
|---|---|---|
| Voll Non-Degradable Shoulder Spacer | Experimental | Voll Non-Degradable Shoulder Spacer Receives: Device: Voll Non-Degradable Shoulder Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related Serious Adverse Events
Incidence of device-related serious adverse events (DRSAEs) related to the spacer.
Measured: Up to 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voll Medical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745647
- Sponsor's protocol ID
- 216CLD
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07745647
- Acronym / sponsor ID
- 216CLD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Voll Medical Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voll Non-Degradable Shoulder Spacer | Experimental | Device: Voll Non-Degradable Shoulder SpacerVoll Non-Degradable Shoulder Spacer |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- Concurrent participation in any other investigational clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voll Non-Degradable Shoulder SpacerVoll Non-Degradable Shoulder Spacer | Device | Voll Non-Degradable Shoulder Spacer |
Primary outcome
Device-related Serious Adverse Events
Time frame: Up to 12 months post-implantation
Incidence of device-related serious adverse events (DRSAEs) related to the spacer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voll Non-Degradable Shoulder Spacer in people with Massive Rotator Cuff Tears and Massive Rotator Cuff Tear, run by Voll Medical Technologies Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related Serious Adverse Events (time frame: Up to 12 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.