Recruiting

PerX360º System

Sponsor:

Interventional Spine, Inc.

Code:

NCT01796535

Conditions

DDD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

DDD

Study ID

NCT01796535

Start date

Nov, 2012

Status verified date

Mar, 2013

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

PerX360º System™

Patients treated with PerX360º System™

Primary outcome measure

  • Fusion [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Michelle Butler

858 220 6904mbutler@i-spineinc.com

Locations

Los Angeles Brain and Spine Institute

Recruiting

Los Angeles, California, United States, 90036

Contacts

Nancy Rappard

323-857-5300rappardnancy@gmail.com

Principal Investigator:

Dr. Rappard

Flagler Hospital

Recruiting

St. Augustine, Florida, United States, 32086

Principal Investigator:

David Greenwald, MD

More Information

Sponsor

Interventional Spine, Inc.

Last update posted

Mar 15, 2013

Last verified

Mar, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Interventional Spine, Inc. on 2013-03-15.