Clinical Evaluation of the VIPUN Balloon Catheter 0.1

ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03239821

Acronym

ANTERO-1

Enrollment

Registered

2017-08-04

Start date

2017-09-25

Completion date

2018-04-30

Last updated

2018-05-04

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

Conditions

Healthy, Motility Disorder, Gastric Emptying

Brief summary

The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Furthermore, this investigation will examine whether gastric motility and emptying as measured in this study are correlated.

Interventions

DEVICEVIPUN Balloon Catheter 0.1 deflated

deflation balloon

DRUGCodeine Phosphate

58.8 mg codeïne phosphate

DRUGPlacebo

Sirupus Simplex

DEVICEVIPUN Balloon Catheter 0.1 inflated

VIPUN Balloon Catheter 0.1 inflated

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed Informed Consent * Aged between and including 18 and 65 years * BMI between and including 18 and 25 * Understand and able to read Dutch * In good health on the basis of medical history * Able to return home without driving a vehicle on visit days 1-4 * Will not operate machines on the same day of treatment (visits 1-4) * Females subjects of childbearing potential are willing to use adequate contraception * Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Design outcomes

Primary

Measure	Time frame	Description
Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.	8 hours	Incidence, frequency, severity, seriousness and relatedness of AEs
Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.	8 hours	Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)
Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.	8 hours	Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)

Secondary

Measure	Time frame	Description
Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon	8 hours	To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.
Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)	8 hours	To explore whether there is a correlation between gastric motility and emptying.

Countries

Belgium

Outcome results

None listed

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