Study of the pH profile in the human gastrointestinal tract, using an ingestible electronic device: the iPill

Completed

• Conditions: 10017943; small bowel disorders; normal values temperature and pH digestive tract

• Registration Number: NL-OMON34774
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Healthy volunteers 18-55 yr old
Informed consent
Weight less than 100 kg.

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Safety:<br /><br>* recording any signs of iPill retention, gastrointestinal bleeding or<br /><br>perforation<br /><br>* studying structural and functional integrity of the iPIll after<br /><br>gastrointestinal passage</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Recording of pH, temperature and time during the iPill*s passage through the<br /><br>gastrointestinal tract (max 26 hrs). Testing two way communications: sending<br /><br>pH/temperature/time data to a remote data recorder worn on the subject*s body<br /><br>and receiving a signal to reprogram the iPill*s behaviour reducing the<br /><br>pH/temperature sampling frequency.</p><br>