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Clinical Evaluation of the VIPUN Balloon Catheter 0.1

NCT03239821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-05-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2018-03-27
Completion
2018-04-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239821 on ClinicalTrials.gov