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A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

NCT03247166 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-08-11

No results posted yet for this study

Summary

The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.

Conditions

  • Lower Back Pain

Interventions

DEVICE

TOPS™ System

The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Principal Investigators

  • Eyal Behrbalk, MD · Hillel Yaffe Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • 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 NCT03247166 on ClinicalTrials.gov