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New Mechatronic Device for Epidural Space Detection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03589391
Enrollment
34
Registered
2018-07-17
Start date
2017-09-01
Completion date
2018-07-04
Last updated
2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Invasive Monitoring of Loss of Resistance During Epidural Injection

Keywords

Epidural injection, loss of resistance detection, mechatronic device

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.

Interventions

DEVICELOR measurement via 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.

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients whose pathology requires specific treatment such as epidural infiltration

Exclusion criteria

* coagulation abnormalities or assumption of anticoagulant drugs

Design outcomes

Primary

MeasureTime frameDescription
Loss of resistance detectionthroughout the epidural infiltration procedureA non invasive device to detect loss of resistance during epidural infiltration

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026