The goal of the current study is to investigate the correlation of IntelliCap generated environmental information (gastrointestinal pH and temperature) with an established nuclear imaging technique. In addition, the functionality of the IntelliCap…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal conditions NEC
Synonym
Health condition
small bowel disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Correlation of nuclear imaging data with environmental data (pH, temperature)
generated by the IntelliCap system with respect to anatomical location.
• Nuclear imaging visualizing the release of 99mTc-pertechnetate in the small
intestine
• Functionality of the IntelliCap (pH/temperature sensors and fidelity of
communication between IntelliCap, portable unit, and control center) in the
human body.
Secondary outcome
• Nuclear imaging visualizing the distribution profile of 99mTc-pertechnetate
released in the small intestine
• Nuclear imaging visualizing distribution of released 99mTc-pertechnetate
within the gastrointestinal tract and in relation to the IntelliCap
• Number and nature of adverse events
Background summary
Miniaturization of medical devices of which the functionality is completely
controlled by microelectronics creates new possibilities for minimally invasive
medical and clinical procedures. The investigational Philips IntelliCap system
consists of a swallowable electronic device (capsule shaped, 26 mm long and 11
mm in diameter), capable of carrying about 300 microliter of liquid payload and
ancillary equipment for real time recording of data. The IntelliCap capsule has
two sensors (pH and temperature) that are used to determine the position of the
device in the GI tract (e.g. low pH in stomach, rise in pH passage through
pylorus, drop in pH passage through ileocecal valve). Propelled by natural
peristalsis along the gastrointestinal tract, it records data (pH and
temperature) from its immediate environment. Based on this information the
operator may start dispensing a payload at a defined anatomical location by
triggering the IntelliCap remotely. The IntelliCap system will be primarily
used to conduct pre-clinical as well as clinical studies to study
bioavailability and other pharmacokinetic parameters of different drug
formulations, released at specified anatomical locations with customized
release profiles, to guide further pharmaceutical formulation and dosage form
development. Future applications may also comprise therapeutic applications
like e.g. controlled intraluminal drug delivery in patients with inflammatory
bowel disease or gastrointestinal cancer.
Study objective
The goal of the current study is to investigate the correlation of IntelliCap
generated environmental information (gastrointestinal pH and temperature) with
an established nuclear imaging technique. In addition, the functionality of the
IntelliCap releasing a payload in the small intestine will be assessed. For
this purpose, the IntelliCap will be loaded with 99mTc-pertechnetate, a
commonly used agent in nuclear medicine imaging to visualize its position as
well as the release and distribution of 99mTc-pertechnetate within the
gastrointestinal tract. These data are required to assess the functional
reliability of the IntelliCap system in terms of real time measuring of
environmental information to determine its anatomical location as well as
payload release at a defined anatomical location in the gastrointestinal tract
in man. The present study will be performed in healthy volunteers.
Study design
Uncontrolled, open label study
Study burden and risks
The study requires ingestion of the IntelliCap, an electronic, medical device
of 26*11 mm after fasting overnight. Subjects will be asked to wear a carrying
strap with a data recorder and relay unit (portable unit) until excretion of
the IntelliCap. Short interruptions (e.g. taking a shower) are allowed. During
night time, the portable unit might be taken off, but needs to be kept as close
as possible to the body. Volunteers need to come to the study center for a
screening visit for assessment of eligibility. A second visit to the clinical
center will comprise ingestion of the IntelliCap in the morning of Day 1
followed by staying at the study center for approximately 8 hours. The end of
study visit (Day 2) will be conducted the following day (about 24 hours after
ingestion of the IntelliCap). After ingestion of the IntelliCap subjects will
be asked to remain fasted until the completion of the dynamic imaging
procedures after which they*ll be offered a sandwich and a soft drink.
Approximately 4 hours after the ingestion of the IntelliCap subjects will be
allowed normal food intake. Subjects are required to undergo both static (up to
approximately 8 times) and dynamic nuclear imaging (twice for 30 minutes with a
break of 15 minutes in between) procedures during their stay at the study
center for approximately 8 hours (during which time the IntelliCap is expected
to have reached the cecum). During dynamic nuclear imaging, subjects will be
asked to remain in the same supine position during the image acquisition
periods (2 times 30 minutes with a 15 minute break in between). One additional
static nuclear imaging will take place at Day 2. Volunteers are asked to
retrieve the IntelliCap after excretion in the stool and return it to the study
center together with the portable unit. If the IntelliCap is not excreted by
the Day 2 visit, subjects will be asked to continue wearing the portable unit
and to come back to the study center once more to return the retrieved
IntelliCap together with the portable unit. Similarly sized pills have been
shown to have an extremely low risk of retention in the gastrointestinal tract
in healthy human subjects. No other risks are anticipated related to the
IntelliCap system.
Radiation exposure: The volunteer will receive 200 MBq 99mTc-pertechnetate
orally by ingesting the Intellicap with a calculated effective dose of 3 mSv/
volunteer. 99mTc-pertechnetate has a short half-life of 6 hours. Additional
details on the risk assessment of radiation exposure can be found in
*Rechtvaardiging stralingsbelasting studieprotocol IntelliCap*.
Healthy volunteers will not have any medical or therapeutic benefit by
participating in this study.
High Tech Campus 4(11)
5656AE Eindhoven
NL
High Tech Campus 4(11)
5656AE Eindhoven
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32762.041.10 |