CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
TransDiscal System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01263054
NCT01263054N/ACompleted
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A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain

Halyard Health·interventional·Posted Dec 20, 2010·Updated Jul 10, 2018

In Brief

A clinical study evaluating TransDiscal System and Medical Management for Back Pain. Completed, enrolled 67 participants across 9 sites.

Detailed Summary

The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will be compared against medical management (standard of care).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.5 years ago

Interventions

TransDiscal Systemdevice

Surgical Procedure using the TransDiscal System to perform disc biacuplasty.

Medical Managementother

Standard medical management, physical therapy, and lifestyle changes.