GENERAL
What is the Heidelberg pH Capsule System?
A radiotelemetric capsule that measures intragastric pH in real time. The patient swallows a tethered capsule that transmits pH to a receiver, while a standardized bicarbonate challenge quantifies how the stomach restores acidity.
Is it invasive?
No. It requires no catheter, no sedation, and no ionizing radiation. The capsule is swallowed and the procedure is performed in a standard exam room.
How long does the test take?
A typical bicarbonate challenge protocol runs about 45 to 90 minutes, with results available the same visit.
Is the device FDA approved?
It is a Class I, 510(k)-exempt, preamendments medical device, classified under 21 CFR 876.1400. Registration of an establishment or listing of a device does not denote FDA approval, clearance, or endorsement.
CLINICAL
What does the test measure?
Intragastric pH over time, and the reacidification response to a bicarbonate challenge — which aids the assessment of gastric acidity and the diagnosis of hypochlorhydria, achlorhydria, and hyperchlorhydria.
Who can order or perform it?
It is for use by qualified healthcare professionals. Federal Law (USA) restricts these devices to sale by or on the order of a physician.
How does it help with PPI decisions?
Objective pre- and post-measurement supports rational review of ongoing PPI therapy and helps distinguish rebound from recurrent disease.
RESEARCH & INDUSTRY
Can it be used in research studies?
Yes. The standardized protocol and explicit endpoints support within-subject crossover designs and multi-site studies of gastric acid dynamics.
Is it suitable for drug development?
It measures intragastric pH directly, supporting acid-reducing-agent DDI work, antisecretory pharmacodynamics, and pH-dependent absorption studies.
How do we get the system for a study?
We provide the system and single-use capsules for the study duration, with calibration standards and protocol support. Use the contact form to scope a study.