Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients (ANTERO-2)

August 30, 2019 updated by: Prof Dr Jan Tack

A Prospective Evaluation of the VIPUN Balloon Catheter 0.2: an Investigational Medical Device for the Monitoring of Gastric Motility in Adult Critically Ill Patients

An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent
  • Of adult age (18 years or older)
  • ICU patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in ICU on enteral feeding.
  • Patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place.

Exclusion Criteria:

  • Contra-indication for (re-) placement of nasogastric feeding catheters.
  • History of gastric or esophageal surgery
  • Any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator
  • Fed by mouth or enterally prior to inclusion
  • Patient is moribund
  • Known pregnancy or breastfeeding women
  • Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIPUN Balloon Catheter
Recording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test.
Device: VIPUN Balloon Catheter
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric motility
Time Frame: 10 hours
Assessed with the VIPUN Balloon Catheter
10 hours
gastric emptying rate
Time Frame: 6 hours
Assessed with 13C-octanoate breath test
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate placement and removal balloon catheter
Time Frame: Day 0 until day 1 (<24 h)
Success rate completing the procedures to place and remove the balloon catheter
Day 0 until day 1 (<24 h)
Safety parameters potentially related to the use of the investigational medical device
Time Frame: Day 0 until day 30
Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.
Day 0 until day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Dr Jan Tack

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S61147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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