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Clinical Evaluation of the VIPUN Balloon Catheter 0.1 (ANTERO-1)

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ClinicalTrials.gov Identifier: NCT03239821
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Motility Disorder Gastric Emptying Device: VIPUN Balloon Catheter 0.1 deflated Drug: Codeine Phosphate Drug: Placebo Device: VIPUN Balloon Catheter 0.1 inflated Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : March 27, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Codeine

Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Placebo - deflated balloon Device: VIPUN Balloon Catheter 0.1 deflated
deflation balloon

Drug: Placebo
Sirupus Simplex
Placebo Comparator: Placebo - inflated balloon Drug: Placebo
Sirupus Simplex

Device: VIPUN Balloon Catheter 0.1 inflated
VIPUN Balloon Catheter 0.1 inflated
Active Comparator: Codeine - delfated balloon Device: VIPUN Balloon Catheter 0.1 deflated
deflation balloon

Drug: Codeine Phosphate
58.8 mg codeïne phosphate
Active Comparator: Codeine - inflated balloon Drug: Codeine Phosphate
58.8 mg codeïne phosphate

Device: VIPUN Balloon Catheter 0.1 inflated
VIPUN Balloon Catheter 0.1 inflated


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239821


Locations
Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03239821     History of Changes
Other Study ID Numbers: S60320
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents