Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03512145

Acronym

ANTERO-2

Enrollment

Registered

2018-04-30

Start date

2018-04-16

Completion date

2019-08-30

Last updated

2019-09-03

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

Conditions

Critical Illness, Delayed Gastric Emptying, Gastric Motor Dysfunction, Intolerance; Nutritional

Brief summary

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

Interventions

DEVICEVIPUN Balloon Catheter

Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

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