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Post-market Study of the TOPS™ System

NCT02234154 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-04-18

No results posted yet for this study

Summary

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.

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

  • Masood Shafafy, MD · Queens Medical Centre Nottingham

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
2014-12-31
Primary Completion
2017-03-31
Completion
2017-05-31

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 NCT02234154 on ClinicalTrials.gov