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Completed

NCT Number: NCT03239821

Clinical Evaluation of the VIPUN Balloon Catheter 0.1

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.

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Key information

Conditions

Healthy Gastric Emptying Motility Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Exclusion criteria

related to possible influence on end-points:

  • Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
  • Using any medication that might affect gastric function or visceral sensitivity
  • Known / suspected current use of illicit drugs
  • Known psychiatric or neurological illness
  • Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator

Exclusion criteria

related to positioning of the catheter:

  • History of heart or vascular diseases like irregular heartbeats, angina or heart attack
  • Nasopharyngeal, upper GI or esophageal surgery in the last 30 days
  • Suspected basal skull fracture or severe maxillofacial trauma
  • History of thermal or chemical injury to upper respiratory tract or esophagus
  • Current esophageal or nasopharyngeal obstruction
  • Known coagulopathy
  • Known esophageal varices

Exclusion criteria

related to codeine administration:

  • History of opioid dependency
  • Known severely decreased kidney or liver function
  • Pregnant or breastfeeding women (pregnancy test will be performed on females with childbearing potential)
  • Known severe lung disease (e.g. asthma or emphysema)
  • Have known side-effects/allergic reactions when taking codeine/morphine
  • Known diabetic, fructose intolerance or malabsorption of glucose or galactose or sucrose-isomalase insufficiency.

Exclusion criteria

related to Sirupus simplex administration:

  • Known diabetic (saccharose), intolerance to or malabsorption of propylene glycol and methyl- and propylparahydroxybenzoate

Exclusion criteria

related to nutrients (Fortimel):

  • Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Fortimel Energy

Treatment and study plan

VIPUN Balloon Catheter 0.1 deflated

Device

deflation balloon

Codeine Phosphate

Drug

58.8 mg codeïne phosphate

Placebo

Drug

Sirupus Simplex

VIPUN Balloon Catheter 0.1 inflated

Device

VIPUN Balloon Catheter 0.1 inflated

Primary outcomes

  1. Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.

    Time frame: 8 hours

    Incidence, frequency, severity, seriousness and relatedness of AEs

  2. Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.

    Time frame: 8 hours

    Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)

  3. Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.

    Time frame: 8 hours

    Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)

Secondary outcomes

  1. Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon

    Time frame: 8 hours

    To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.

  2. Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)

    Time frame: 8 hours

    To explore whether there is a correlation between gastric motility and emptying.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ANTERO-1

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2017
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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