Critical IllnessANTERO-2NCT03512145
Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients
A study testing VIPUN Balloon Catheter in people with Critical Illness and Intolerance; Nutritional, run by Prof Dr Jan Tack at 1 site in Belgium.
Trial summary
An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intolerance; Nutritional, Delayed Gastric Emptying
- What is being tested?
- VIPUN Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Critical Illness, Intolerance; Nutritional, Delayed Gastric Emptying, Gastric Motor Dysfunction
- Being tested
- VIPUN Balloon Catheter
- Medical subject headings
- Critical Illness, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPUN Balloon CatheterDevice
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VIPUN Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric motility
Assessed with the VIPUN Balloon Catheter
Measured: 10 hours
gastric emptying rate
Assessed with 13C-octanoate breath test
Measured: 6 hours
Secondary outcomes (2)
Success rate placement and removal balloon catheter
Success rate completing the procedures to place and remove the balloon catheter
Measured: Day 0 until day 1 (<24 h)
Safety parameters potentially related to the use of the investigational medical device
Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.
Measured: Day 0 until day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start16 Apr 2018
- Primary completion1 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Dr Jan Tack
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512145
- Sponsor's protocol ID
- S61147
- Acronym
- ANTERO-2
- Status last verified
- Aug 2019
- First submitted
- 30 Mar 2018
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03512145
- Acronym / sponsor ID
- ANTERO-2 / S61147
- Conditions
- Critical Illness, Intolerance; Nutritional, Delayed Gastric Emptying, Gastric Motor Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prof Dr Jan TackUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIPUN Balloon Catheter | Experimental | Device: VIPUN Balloon CatheterRecording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIPUN Balloon CatheterGastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours. | Device | VIPUN Balloon Catheter |
Primary outcome
Gastric motility
Time frame: 10 hours
Assessed with the VIPUN Balloon Catheter
gastric emptying rate
Time frame: 6 hours
Assessed with 13C-octanoate breath test
2 secondary outcomes
Success rate placement and removal balloon catheter
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPUN Balloon Catheter in people with Critical Illness and Intolerance; Nutritional, run by Prof Dr Jan Tack at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric motility (time frame: 10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.