NIPH Clinical Trials Search

Development of a magnetic sensor-based method for detecting digital chip signals in placebo tablet

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Healthy volunteers
Date of first enrollment	10/02/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	(Medical Devices) Magnetic Field Measurement System (Test Equipment) 1) Tunnel Magnetoresistance (TMR) Sensor A magnetic sensor that detects magnetic field signals. 2) Amplifier Amplifies the measured magnetic field signals. 3) A/D Converter Converts analog signals into digital signals. 4) Magnetic Field Signal Measurement and Analysis Software Software used to record and analyze IEM magnetic field waveforms. 5) PC with Installed Software A dedicated PC prepared for this study, with the software installed for use. Medication Management System 1) Ingestible Event Marker (IEM) A chip that emits signals in the stomach. Voltage: 1 to 1.6 V Current: about 1 mA Size: about 5 mm Frequency: 12.8 kHz (data packet), 20 kHz (beacon) Dataset: One set consists of three beacons plus one data packet, repeatedly transmitted. 2) Miniature IEM in Tablet (MIT) Placebo tablets containing an IEM chip. 3)OAPI Patch Receives IEM voltage signals and transmits low-power signals to connected devices via Bluetooth. The patch is attached with adhesive tape at a predefined position on the right side of the torso. 4) OAPI Software Software installed on a device to receive information from the patch. 5) Smartphone with OAPI Software A dedicated smartphone prepared for this study, with OAPI software installed. The smartphone receives low-power signals transmitted from the OAPI patch and displays the results on its screen.

Outcome(s)

Primary Outcome

To evaluate whether IEM magnetic field signals generated inside the body can be detected externally using a TMR sensor at a distance of 1 cm from the body surface.

Secondary Outcome

1) Total number of packets (data packets, beacons) 2) Number of data packets and beacons, respectively 3) Position of the TMR sensor at which the IEM magnetic field signal reaches its maximum amplitude 4) Dependence of the IEM magnetic field signal amplitude on the distance between the body surface and the TMR sensor 5) Estimated distance dependence of the IEM magnetic field signal amplitude from the IEM chip

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Male
Include criteria	1) Those who have given written consent to participate in the study 2) Healthy individuals (Confirmed by questionnaire) 3) Men aged 18 to 65
Exclude criteria	1) Problems with swallowing function 2) Presence of organic or functional gastrointestinal disorders Examples: A history of gastrointestinal surgery, colonic diverticulosis, inflammatory bowel disease, chronic constipation, irritable bowel syndrome, intestinal obstruction, or any other gastrointestinal structural or functional disorder as determined by doctors. 3) Abnormalities in the skin of the abdomen 4) Allergies to medications or tape, or tape rash (Confirmed via questionnaire) 5) Participants with non-removable metal devices or equipment in the chest or abdomen Examples: Pacemakers, bolts or plates, nerve stimulation devices, etc. 6) Participants deemed unsuitable for this study by the doctor