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

NCT03512145 | Completed

• 1 other identifier: S61147
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Gastric motility

  Assessed with the VIPUN Balloon Catheter

  10 hours

• gastric emptying rate

  Assessed with 13C-octanoate breath test

  6 hours

Secondary Outcomes (2)

• Success rate placement and removal balloon catheter

  Day 0 until day 1 (<24 h)

• Safety parameters potentially related to the use of the investigational medical device

  Day 0 until day 30

Study Arms (1)

VIPUN Balloon Catheter

EXPERIMENTAL

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

Interventions

VIPUN Balloon Catheter DEVICE

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

VIPUN Balloon Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patient is moribund
• Known pregnancy or breastfeeding women
• Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)

Sponsors & Collaborators

• Prof Dr Jan Tack: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Critical Illness; Gastroparesis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Member of staff hepato-gastroenterology

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 30, 2018
• Study Start: April 16, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 30, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)