Wireless esophageal pH capsule for patients with gastroesophageal reflux disease: A multicenter clinical study

Table 1 Inclusion and exclusion criteria

Inclusion criteria

Age ≥ 18 yr and ≤ 65 yr

Typical symptoms: regurgitation and heartburn

Atypical symptoms: belching, chest pain, pharyngeal burning, foreign body sensations, chronic unexplained pharyngitis, hoarseness, bronchitis, and asthma

Proton pump inhibitor therapy-positive

Written informed consent

Exclusion criteria

Nasopharynx or upper esophagus obstruction

Esophageal varices and severe esophageal mucosal erosion

Severe esophageal motility disorder (e.g., achalaisa, scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, and myopathy)

In vivo congenital gastrointestinal malformation, gastrointestinal obstruction, perforation, stricture, or fistula

A recent history of stomach surgery or gastrointestinal bleeding (within the past 6 mo)

A history of bleeding tendency and taking anticoagulant drugs in the long term

Any implanted electrical device, such as cardiac pacemakers

Allergy to the polymer materials

Various acute enteritis, severe ischemic disease, or radioactive colitis

Pregnancy/lactation

Unstable cardiopathy, psychotic diseases arrhythmia cordis, or being uncooperative

Table 2 Comparison of esophageal acid exposure measured during 24 h of simultaneous recordings in 45 patients with pH capsule (JSPH-1) and the conventional pH measurement system

Parameter	JSPH-1	MMS	P-value1
Reflux episodes (n)	17 (8-36.5)	16 (6-39.5)	0.305
Reflux episodes > 5 min (n)	0 (0-2)	1 (0-3.5)	0.058
Longest reflux time (min)	5.4 (2.1-14.2)	6.5 (1.8-15.4)	0.125
pH < 4, total time (min)	14.6 (4.0-53.8)	20 (5.6-54.1)	0.014
pH < 4, percentage of total time (%)	1.2 (0.3-4.1)2	1.5 (0.5-4.0)2	0.171

¹Wilcoxon signed rank test;

²Results are median (25^th-75^th). MMS: Measurement system.