small bowel disorders normal values temperature and pH digestive tract
Conditions
Interventions
None listed
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers 18-55 yr old Informed consent Weight less than 100 kg.
Exclusion criteria
Exclusion criteria: Subjects with known or suspected gastrointestinal strictures, including (suspected) Crohn*s disease Subjects with pacemakers or other implanted electro-medical devices Subjects with swallowing disorders Pregnancy (females) or unwillingness to institute anticonceptive measures (males and females) until > 1 month after study termination Subjects using acid reducing medication Subjects using NSAID* s Subject with known cardiopulmonary or any other gastrointestinal disorders Subjects with ASA > 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: * recording any signs of iPill retention, gastrointestinal bleeding or perforation * studying structural and functional integrity of the iPIll after gastrointestinal passage | — |
Secondary
| Measure | Time frame |
|---|---|
| Recording of pH, temperature and time during the iPill*s passage through the gastrointestinal tract (max 26 hrs). Testing two way communications: sending pH/temperature/time data to a remote data recorder worn on the subject*s body and receiving a signal to reprogram the iPill*s behaviour reducing the pH/temperature sampling frequency. | — |
Countries
Netherlands
Outcome results
None listed