NCT03239821

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Motility Disorder
• Gastric Emptying

Interventions

Type	Name	Description
DEVICE	VIPUN Balloon Catheter 0.1 deflated	deflation balloon
DRUG	Codeine Phosphate	58.8 mg codeïne phosphate
DRUG	Placebo	Sirupus Simplex
DEVICE	VIPUN Balloon Catheter 0.1 inflated	VIPUN Balloon Catheter 0.1 inflated

Timeline

• Start date: 2017-09-25
• Primary completion: 2018-03-27
• Completion: 2018-04-30
• First posted: 2017-08-04
• Last updated: 2018-05-04

Locations

1 site across 1 country: Belgium