Voll Degradable Shoulder Spacer FIH Study

NCT ID: NCT07208448

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-09

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Massive Rotator Cuff Tear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Voll Degradable Shoulder Spacer

Group Type EXPERIMENTAL

Voll Degradable Shoulder Spacer

Intervention Type DEVICE

Voll Degradable Shoulder Spacer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Voll Degradable Shoulder Spacer

Voll Degradable Shoulder Spacer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Voll Medical Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assuta Ashdod Hospital

Ashdod, , Israel

Site Status RECRUITING

Ichilov (Sourasky Medical Center)

Tel Aviv, , Israel

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sahar Boostenay

Role: primary

+97254421243

Sahar Boostenay

Role: primary

+972544621243

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

053CLD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perform Humeral System Study
NCT05067543 RECRUITING
Maxera Large Cups - Canada
NCT04348968 TERMINATED