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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 3, 2017
First Posted Date  ICMJE August 4, 2017
Last Update Posted Date May 4, 2018
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03239821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the VIPUN Balloon Catheter 0.1
Official Title  ICMJE ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Healthy
  • Motility Disorder
  • Gastric Emptying
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Sham Comparator: Placebo - deflated balloon
    Interventions:
    • Device: VIPUN Balloon Catheter 0.1 deflated
    • Drug: Placebo
  • Placebo Comparator: Placebo - inflated balloon
    Interventions:
    • Drug: Placebo
    • Device: VIPUN Balloon Catheter 0.1 inflated
  • Active Comparator: Codeine - delfated balloon
    Interventions:
    • Device: VIPUN Balloon Catheter 0.1 deflated
    • Drug: Codeine Phosphate
  • Active Comparator: Codeine - inflated balloon
    Interventions:
    • Drug: Codeine Phosphate
    • Device: VIPUN Balloon Catheter 0.1 inflated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2017)
23
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03239821
Other Study ID Numbers  ICMJE S60320
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP