Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in... | NCT03512145

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

NCT03512145

Sponsor

Prof Dr Jan Tack

Status

Completed

Last Update Posted

Sep 3, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Critical Illness
Intolerance; Nutritional
Delayed Gastric Emptying
Gastric Motor Dysfunction

Interventions

VIPUN Balloon Catheter

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Mar 30, 2018

First Submission Date that Met QC Criteria

Apr 18, 2018

First Posted Date

Apr 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2019

Last Update Posted Date

Sep 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Dr Jan Tack, Member of staff hepato-gastroenterology, Universitaire Ziekenhuizen KU LeuvenSponsor-Investigator

Lead Sponsor

Prof Dr Jan TackOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VIPUN Balloon Catheter	Device	Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.	VIPUN Balloon Catheter

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Success rate placement and removal balloon catheter	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven		Leuven	Vlaams-Brabant	3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D018589	Gastroparesis

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D013272	Stomach Diseases

Browse Leaves

Not provided

Browse Branches

Not provided