New Mechatronic Device for Epidural Space Detection

Not Applicable

Completed

• Conditions: Non Invasive Monitoring of Loss of Resistance During Epidural Injection
• Interventions: Device: LOR measurement via device

• Registration Number: NCT03589391
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2017-12-23
• Status Verified: 2018-07
• Study Completion: 2018-07-04
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• patients whose pathology requires specific treatment such as epidural infiltration

Exclusion Criteria

• coagulation abnormalities or assumption of anticoagulant drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procedures with the use of device for LOR monitoring	LOR measurement via device	Patients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used.

Primary Outcome Measures

Name	Time	Method
Loss of resistance detection	throughout the epidural infiltration procedure	A non invasive device to detect loss of resistance during epidural infiltration

Trial Locations

Locations (2)

Campus Bio Medico; 🇮🇹 Rome, RM, Italy

University Hospital Campus BioMedico; 🇮🇹 Rome, Italy