NCT03500887

Brief Summary

In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

December 8, 2015

Last Update Submit

April 16, 2018

Conditions

Functional Disorders of Stomach

Outcome Measures

Primary Outcomes (1)

  • Intragastric pressure during food intake

    The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.

    max 3 hours

Study Arms (2)

1. Bag inflated so that intrabagpressure increases with 2 mmHg

OTHER
Device: intragastric bag

2. Bag inflated to ¾ volume of 1

OTHER
Device: intragastric bag

Interventions

intragastric bagDEVICE
1. Bag inflated so that intrabagpressure increases with 2 mmHg2. Bag inflated to ¾ volume of 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • They are between 18-60 years old.
  • Male and female.
  • Patients must provide witnessed written informed consent prior to any study procedures being performed.

You may not qualify if:

  • They are older than 60 years old.
  • Have severely decreased kidney function.
  • Have severely decreased liver function.
  • Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
  • Have severe lung disease.
  • Have severe psychiatric illness or neurological illness.
  • Have any gastrointestinal disease.
  • Have any dyspeptic symptoms.
  • Women that are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

Study Officials

  • Jan Tack, Prof.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 8, 2015

First Posted

April 18, 2018

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

BE(1)