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

Philips Electronics Nederland B.V.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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

•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

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