CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Epiduroscopyprocedure
Likely dose
Not stated in record
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Search/NCT03863067
NCT03863067N/ACompleted

Assessment Of Clinical Effectiveness, Security And Correlation With Radiological Changes In Patients With Lumbar Stenosis Treated With Epiduroscopy

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz·interventional·Posted Mar 5, 2019·Updated Mar 6, 2024

In Brief

A clinical study evaluating Epiduroscopy for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication. Completed, enrolled 40 participants across 1 site.

Detailed Summary

It will be done a prospective Study involving 38 patients with lumbar stenosis. A magnetic resonance (MR) imaging study and a electromyographic study will be done previously and 3 months after the epiduroscopy to confirm radiologic or neurophysiological changes. During the technic it will be used different instruments, an endoscope developed for its use in the epidural space (Resascope), a Fogarty balloon (Resaloon) to dilate the space near the epidural recess where it will be try to decrease the ligamentum flavum using the Resaflex, an instrument with Quantum Molecular Resonance for tissue coablation, in order to get less symptomatic lumbar stenosis. The investigators will compare qualitative and quantitative variables at baseline and 1, 3, 6, ant 12 months after the epiduroscopy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 5, 2019
Enrollment StartOct 15, 2018
Primary CompletionOct 15, 2022
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 7.3 years ago

Interventions

Epiduroscopyprocedure

Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.