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Epidural Space Verification With the CompuFlo®

NCT03625232 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2019-12-20

No results posted yet for this study

Summary

The purpose of this single arm open-label study is to capture additional data that can add to the original COMPASS (CompuFlo® Assessment Study) clinical trial database that supported the 510(k) application, which was given clearance by the FDA on June 9, 2017.

Conditions

  • Epidural; Anesthesia

Interventions

DEVICE

CompuFlo® Epidural Computer Controlled System

The CompuFlo® Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the HCP to perform epidural anesthesia and epidural injections using standard methods. Currently, HCPs rely on their subjective perception to feel a "loss of resistance" when inserting an epidural needle to identify the epidural space. The CompuFlo® Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017.

Sponsors & Collaborators

  • European e-Learning School in Obstetric Anesthesia

    lead OTHER

Principal Investigators

  • Giorgio Capogna, MD · European e-Learning School in Obstetric Anesthesia

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Device
Yes

Countries

  • Belgium
  • Chile
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625232 on ClinicalTrials.gov