NCT03863067

Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Interventions

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

Timeline

• Start date: 2018-10-15
• Primary completion: 2022-10-15
• Completion: 2022-10-15
• First posted: 2019-03-05
• Last updated: 2024-03-06

Locations

1 site across 1 country: Spain