Remotely controlled, small intestinal release of 99mTcpertechnetate using an ingestible electronic device: the IntelliCap

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Healthy volunteers 18-55 yrs old,
Signed informed consent
Body Mass Index 18-30 kg/m2
All subjects must use a safe contraception method following ingestion of the IntelliCap (female subjects during one menstrual cycle or one month (whichever is longer), male subjects during 3 months)
Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent

Exclusion Criteria

Subjects with known or suspected gastrointestinal strictures, including (suspected) inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding or major abdominal surgery;
Subjects with pacemakers or other implanted electro-medical devices;
Subjects with swallowing disorders;
Pregnant or breastfeeding women;
Unwillingness to institute anti-contraceptive measures for the specified period;
Subjects using acid reducing medication;
Subjects using NSAID*s;
Subject with known cardiopulmonary or any other gastrointestinal disorders;
Subjects with ASA physical status classification system >1;
Subjects are not allowed to undergo MRI studies during the time the IntelliCap has not been excreted;
History of multiple and recurring allergies or present allergy or allergy to the investigational compound class / device materials being used in this study.;
Participation in a clinical research study within one month prior to participating in the current study;
Previous participation in any clinical research study with radiation exposure;
Subjects being unable or unwilling to provide informed consent, including legally incapacitated or institutionalized subjects

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Correlation of nuclear imaging data with environmental data (pH, temperature)<br /><br>generated by the IntelliCap system with respect to anatomical location.<br /><br>• Nuclear imaging visualizing the release of 99mTc-pertechnetate in the small<br /><br>intestine<br /><br>• Functionality of the IntelliCap (pH/temperature sensors and fidelity of<br /><br>communication between IntelliCap, portable unit, and control center) in the<br /><br>human body.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Nuclear imaging visualizing the distribution profile of 99mTc-pertechnetate<br /><br>released in the small intestine<br /><br>• Nuclear imaging visualizing distribution of released 99mTc-pertechnetate<br /><br>within the gastrointestinal tract and in relation to the IntelliCap<br /><br>• Number and nature of adverse events</p><br>