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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01796535
Other study ID # TP201
Secondary ID
Status Recruiting
Phase N/A
First received December 10, 2012
Last updated March 13, 2013
Start date November 2012
Est. completion date June 2013

Study information

Verified date March 2013
Source Interventional Spine, Inc.
Contact Michelle Butler
Phone 858 220 6904
Email mbutler@i-spineinc.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only


Related Conditions & MeSH terms


Locations

Country Name City State
United States Los Angeles Brain and Spine Institute Los Angeles California
United States Flagler Hospital St. Augustine Florida

Sponsors (1)

Lead Sponsor Collaborator
Interventional Spine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fusion Image Assessment 1 year No
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