alpHaONE Wireless pH Capsule System
The alpHaONE wireless pH capsule monitoring system enables extended esophageal acid exposure measurement without catheter-based tethering, providing up to 96 hours of continuous pH data for thorough GERD diagnosis.
Product Overview
Traditional catheter-based pH monitoring limits patient activity and may not capture the full range of reflux events due to measurement duration constraints and patient discomfort affecting normal behavior patterns. Wireless pH capsule technology addresses these limitations through untethered measurement over extended timeframes.
alpHaONE delivers diagnostic capability comparable to the Medtronic Bravo system with design optimizations for the Chinese healthcare market. The compact capsule attaches to esophageal mucosa via vacuum suction delivery, eliminating the need for transnasal catheter placement.
Key Features
For GERD patients who need extended acid exposure data, Jinshan’s alpHaONE wireless pH capsule records up to 96 hours of continuous pH data without transnasal catheter discomfort, approved with NMPA and CE marks.
- Extended Monitoring: Up to 96-hour continuous pH recording captures intermittent reflux patterns
- Catheter-Free: Wireless design eliminates transnasal catheter discomfort
- Rapid Sampling: pH measurement every 3 seconds ensures detection of brief reflux episodes
- Compact Design: Minimized capsule size improves patient tolerance
- Wide Transmission Range: 3-meter data transmission distance enables normal daily activities
- Vacuum Attachment: Suction-based mucosal fixation ensures stable capsule positioning
Technical Specifications
For GERD diagnosis and pre-surgical evaluation, alpHaONE samples esophageal pH every 3 seconds over up to 96 hours, transmitting data wirelessly within a 3-meter range from vacuum-attached mucosa placement.
| Parameter | Specification |
|---|---|
| Monitoring Duration | Up to 96 hours |
| Sampling Frequency | Every 3 seconds |
| Data Transmission Range | 3 meters |
| Attachment Method | Vacuum suction to mucosa |
| Placement | Lower esophageal sphincter region |
| Capsule Passage | Natural excretion post-study |
Clinical Applications
alpHaONE addresses the diagnostic challenge of proving pathological acid exposure in patients with suspected GERD. Extended monitoring increases the probability of capturing significant reflux events and enables correlation with patient-reported symptoms.
Primary Indications:
- GERD diagnosis when empiric PPI therapy fails
- Pre-surgical evaluation before anti-reflux procedures
- Atypical reflux presentations (chronic cough, laryngitis, asthma)
- Documentation of acid exposure in medico-legal contexts
Diagnostic Parameters:
- Acid exposure time (AET) percentage
- DeMeester score calculation
- Symptom-reflux correlation indices
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Approved | Yes |
| Europe (CE Mark) | Approved | Yes |
| United States (FDA) | Not Cleared | - |
The system provides a domestic alternative to imported wireless pH monitoring platforms in the Chinese market.
Frequently Asked Questions
How does alpHaONE compare to catheter-based pH monitoring?
Wireless capsule monitoring offers patient comfort advantages and extended recording duration compared to 24-hour catheter studies. The untethered design allows patients to maintain normal eating, sleeping, and activity patterns during the monitoring period.
How is the alpHaONE capsule placed?
A conveyor device delivers the capsule to the lower esophageal sphincter region, where vacuum suction attaches it to the esophageal mucosa. The procedure is typically performed during upper endoscopy or as a standalone transoral placement.
What happens to the capsule after the study?
The capsule naturally detaches from the esophageal wall (typically within 7-10 days) and passes through the gastrointestinal tract for excretion. Patients are advised to report any symptoms of retained capsule, though complications are rare.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
