Completed

NCT Number: NCT03589391

New Mechatronic Device for Epidural Space Detection

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.

Completed

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Key information

Conditions

Non Invasive Monitoring of Loss of Resistance During Epidural Injection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio Medico, Rome, RM, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients whose pathology requires specific treatment such as epidural infiltration

Exclusion criteria

coagulation abnormalities or assumption of anticoagulant drugs

Treatment and study plan

LOR measurement via device

Device

The epidural technique is totally performed in a sterile field without any harm to the patient. The LOR measurement is monitored via the bespoke device used during the epidural procedure.

Primary outcomes

Loss of resistance detection

Time frame: throughout the epidural infiltration procedure

A non invasive device to detect loss of resistance during epidural infiltration

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

A New Pressure Guided Mechatronic Tool for Epidural Space Detection: Feasibility Assessment in a Clinical Scenario

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Jul 17, 2018
Registry last updated: Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.