Obesity severe overweight
Conditions
Interventions
The subjects enrolled in the study will ingest a single capsule under
supervision of the medical team of investigators. The balloon will contain a
radio-opaque tracer visible on X-ray. Weekly X-rays
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18-80 years of age Able and willing to sign an informed consent document BMI of 30-39.9 kg/m^2 Sufficient and stable medical health Must have a primary care physician
Exclusion criteria
Exclusion criteria: Signs/symptoms of gastroduodenal ulcer disease (in history or present) Poorly controlled diabetes or diabetes >10yr Signs/symptoms of oesophageal or gastric disease (in history or present) Signs/symptoms of dysmotility of gastrointestinal tract Use of opioid drugs (past six weeks or present) Female subject is pregnant or suspected to be pregnant, or lactating Previous bariatric, gastric or oesophageal surgery Swallowing disorders Illicit drug use or alcohol abuse Participation in other clinical study within past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of survival of the balloon inside the stomach is the main outcome of this study. Furthermore, a safety analysis will assess the occurrence of adverse events (AEs), serious adverse device effects (SADEs) and serious adverse events (SAE), monitored from the moment of ingestion of the capsule up to two weeks after observed digestion. Self-reported scores on symptoms of reflux and dyspepsia will complement the safety analysis. | — |
Countries
Netherlands
Outcome results
None listed