New Mechatronic Device for Epidural Space Detection

Not Applicable

Completed

• Conditions: Non Invasive Monitoring of Loss of Resistance During Epidural Injection

• 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

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