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Post-market Study of the TOPS™ System

NCT01933607 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-04-18

No results posted yet for this study

Summary

The study is being conducted to evaluate look the TOPS System when used in patients with degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates for spinal fusion.

Conditions

  • Lumbar Spinal Stenosis
  • Spondylolisthesis

Interventions

DEVICE

TOPS System

Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.

Sponsors & Collaborators

  • Premia Spine

    lead INDUSTRY

Principal Investigators

  • John Fowler, MD · University Southampton Hospital

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United Kingdom

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 NCT01933607 on ClinicalTrials.gov