alpHaFLEX Impedance-pH Monitoring System

The alpHaFLEX system combines multichannel intraluminal impedance (MII) measurement with pH monitoring to provide full reflux characterization, detecting both acid and non-acid reflux episodes that pH-alone monitoring would miss.

Product Overview

Standard pH monitoring identifies acid reflux but cannot detect weakly acidic or non-acid reflux events that may cause symptoms in patients on proton pump inhibitor therapy. alpHaFLEX addresses this diagnostic gap through impedance measurement that detects bolus movement regardless of pH content.

The combined modality enables differentiation between acid reflux (pH < 4), weakly acidic reflux (pH 4-7), and non-acid reflux (pH > 7), providing a complete picture of esophageal exposure for patients with persistent symptoms despite acid suppression therapy.

Key Features

At 24-hour recording duration, the alpHaFLEX from Jinshan combines multichannel impedance and pH measurement to detect acid, weakly acidic, and non-acid reflux episodes that pH-only monitoring misses.

• Dual Modality: Combined impedance and pH measurement in single catheter system
• Multichannel Detection: Multiple impedance sensing zones along catheter length
• Complete Reflux Characterization: Distinguishes acid, weakly acidic, and non-acid episodes
• Bolus Transit Assessment: Evaluates esophageal clearance function
• Gas Reflux Detection: Identifies aerophagia and gaseous reflux
• Symptom Correlation: Links patient-reported symptoms to objectively recorded events

Technical Specifications

At 24-hour standard recording duration via transnasal catheter, alpHaFLEX combines impedance and pH channels with antimony electrode measurement, backed by NMPA and CE approvals for complex GERD cases.

Clinical Applications

alpHaFLEX fills the diagnostic role for complex GERD cases where standard evaluation proves inconclusive. The system is particularly valuable in patients continuing to experience symptoms despite adequate acid suppression.

Primary Indications:

• Persistent GERD symptoms on PPI therapy
• Pre-surgical evaluation requiring thorough reflux documentation
• Differentiation between functional heartburn and NERD
• Evaluation of atypical reflux presentations
• Assessment of aerophagia and supragastric belching

Diagnostic Outputs:

• Total reflux episode count (acid + non-acid)
• Bolus exposure percentage
• Proximal extent of reflux events
• Symptom association probability (SAP)
• Symptom index (SI) correlation

Regulatory Status

The system has been incorporated into Chinese GERD diagnostic consensus guidelines as a recommended modality for complex cases.

Frequently Asked Questions

When should alpHaFLEX be used instead of pH-only monitoring?

Combined impedance-pH monitoring is preferred when patients have symptoms despite PPI therapy, when non-acid reflux is suspected, or when thorough pre-surgical characterization is required. pH-only monitoring remains appropriate for initial evaluation of treatment-naive patients.

How is alpHaFLEX different from alpHaONE?

alpHaFLEX uses a catheter-based system providing combined impedance and pH measurement, while alpHaONE is a wireless capsule measuring pH only. alpHaFLEX offers broader reflux characterization but requires transnasal catheter placement.

What is the clinical significance of non-acid reflux?

Non-acid reflux episodes can cause symptoms through volume-related esophageal distension and potentially through bile acid content. Identifying non-acid reflux explains symptom persistence in patients with adequate acid suppression and may influence surgical decision-making.