The PerX360º System™ Registry (OptiLIF™)

March 13, 2013 updated by: Interventional Spine, Inc.

An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™

This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.

Study Overview

Status

Unknown

Conditions

Detailed Description

For all patients participating in the registry, the following outcomes will be analyzed:

  • Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
  • Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
  • Change in Oswestry Disability Index (ODI) score from baseline
  • Proportion of patients with a device related complication
  • Proportion of patients with lack of revision, removal, or reoperation
  • Proportion of patients with radiographic fusion

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90036
        • Recruiting
        • Los Angeles Brain and Spine Institute
        • Contact:
        • Principal Investigator:
          • Dr. Rappard
    • Florida
      • St. Augustine, Florida, United States, 32086
        • Recruiting
        • Flagler Hospital
        • Principal Investigator:
          • David Greenwald, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult subjects treated with the Optiport™ and Opticage™ products

Description

Inclusion Criteria:

  • Patient understands the nature of the procedure and provides written informed consent
  • Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
  • Age > 18 years
  • Patient is treated with the Optiport™ and Opticage™ products

Exclusion Criteria:None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PerX360º System™
Patients treated with PerX360º System™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: 1 year
Image Assessment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Interventional Spine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

February 19, 2013

First Posted (ESTIMATE)

February 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • TP201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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