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Clinical Trial 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.


Clinical Trial Description

The investigators perform the Interventional Endoscopic Spinal Surgical (IESS) ,with the different instruments mentioned above. The Resaflex wich use Quantum Molecular Resonance, through combination of different frequencies in the range of the radio-frequency, emit quantum in resonance and produce lesion and coagulation; The objective is to reach the ligamentum flavum doing lesions to diminish the stenosis caused by hypertrophic ligamentum over all in the recess area near the radicular nerve. To increase the security of the procedure the investigators introduce for the first time , neurophysiological monitoring. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03863067
Study type Interventional
Source Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact
Status Completed
Phase N/A
Start date October 15, 2018
Completion date October 15, 2022

See also
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