An interventional study of VIPUN Balloon Catheter in Healthy, sponsored by Prof Dr Jan Tack. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by Prof Dr Jan Tack · Not applicable, Interventional, and Basic science
A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.
Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.
Prof Dr Jan Tack is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Infusion rate = 25 ml/h * Radiography: confirmation balloon position * VIPUN Balloon Catheter * 13C-Octanoate Breath Test o
Device: VIPUN Balloon Catheter
* Infusion rate = 75 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Test
Device: VIPUN Balloon Catheter
* Infusion rate = 250 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Testt
Device: VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Also known as: VIPUN system
Motility
Motility index (MI) measured with the VIPUN Balloon Catheter.
Time frame: 8 hour
Gastric emptying rate (13C-Octanoate Breath Test)
Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.
Time frame: 8 hour
Gastric emptying rate (Magnetic resonance imaging)
Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging
Time frame: Conditions B and C: 4 hour.
Satiation
Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation).
Time frame: 6 hour
Safety profile VIPUN Balloon Catheter
Incidence, frequency, severity, seriousness and relatedness of AE's
Time frame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Feasibility VIPUN Balloon Catheter related procedures
Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter
Time frame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Reliability manual position check
Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter
Time frame: Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0).
Position catheter at t=480.
Qualitative assessment of the migration of the catheter over the course of the study procedures.
Time frame: During Condition A only: at t=480 minutes (after cessation motility recording).
Epigastric symptoms
Subjective epigastric symptom scores at a 30-minute interval. 3 Visual Analogue Scales (100 mm, 0=absent, 100= maximal sensation). Scale 1: Nausea, Scale 2: Bloating, Scale 3: Pain.
Time frame: 6 hours
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Prof Dr Jan Tack