NCT07745647

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Massive Rotator Cuff TearsMassive Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Device-related Serious Adverse Events

    Incidence of device-related serious adverse events (DRSAEs) related to the spacer.

    Up to 12 months post-implantation

Study Arms (1)

Voll Non-Degradable Shoulder Spacer

EXPERIMENTAL

Voll Non-Degradable Shoulder Spacer

Device: Voll Non-Degradable Shoulder Spacer

Interventions

Voll Non-Degradable Shoulder SpacerDEVICE

Voll Non-Degradable Shoulder Spacer

Voll Non-Degradable Shoulder Spacer

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
  • Concurrent participation in any other investigational clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta Ashdod Hospital

Ashdod, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 4, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)