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Safety and Efficacy of the CarboClear Pedicle Screw System

NCT02626624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-04-27

Study results available
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Summary

The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral spine.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis, Grade 1

Interventions

DEVICE

Implantation of the CarboClear Pedicle Screw System

Sponsors & Collaborators

  • CarboFix Orthopedics Inc.

    collaborator UNKNOWN

  • CarboFix Orthopedics Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-27
Primary Completion
2022-12-28
Completion
2022-12-28
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626624 on ClinicalTrials.gov