Clinical Evaluation of the VIPUN Balloon Catheter 0.1

NCT03239821 | Completed

• 1 other identifier: S60320
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Motility Disorder; Gastric Emptying

Outcome Measures

Primary Outcomes (3)

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

  Incidence, frequency, severity, seriousness and relatedness of AEs

  8 hours

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

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

  8 hours

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

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

  8 hours

Secondary Outcomes (2)

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

  8 hours

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

  8 hours

Study Arms (4)

Placebo - deflated balloon

SHAM COMPARATOR

Device: VIPUN Balloon Catheter 0.1 deflated; Drug: Placebo

Placebo - inflated balloon

PLACEBO COMPARATOR

Drug: Placebo; Device: VIPUN Balloon Catheter 0.1 inflated

Codeine - delfated balloon

ACTIVE COMPARATOR

Device: VIPUN Balloon Catheter 0.1 deflated; Drug: Codeine Phosphate

Codeine - inflated balloon

ACTIVE COMPARATOR

Drug: Codeine Phosphate; Device: VIPUN Balloon Catheter 0.1 inflated

Interventions

VIPUN Balloon Catheter 0.1 deflated DEVICE

deflation balloon

Codeine - delfated balloon; Placebo - deflated balloon

Codeine Phosphate DRUG

58.8 mg codeïne phosphate

Codeine - delfated balloon; Codeine - inflated balloon

Placebo DRUG

Sirupus Simplex

Placebo - deflated balloon; Placebo - inflated balloon

VIPUN Balloon Catheter 0.1 inflated DEVICE

VIPUN Balloon Catheter 0.1 inflated

Codeine - inflated balloon; Placebo - inflated balloon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Codeine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: August 4, 2017
• Study Start: September 25, 2017
• Primary Completion: March 27, 2018
• Study Completion: April 30, 2018
• Last Updated: May 4, 2018

Record last verified: 2017-07

Locations

BE (1)