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The feasibility and safety of a Newly pH capsule developed in China: a multi-center clinical study

The feasibility and safety of a Newly pH capsule developed in China: a multi-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDT-12002374
Enrollment
Unknown
Registered
2012-07-23
Start date
2010-11-23
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease

Interventions

Gold Standard:
Index test:

Sponsors

Xinqiao Hospital,the Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were as follows: 1. Typical symptoms: regurgitation, heartburn, belching, chest pain, pharyngeal burning or foreign body sensation; 2. Atypical symptoms: chronic unexplained pharyngitis, hoarseness, bronchitis, asthma; 3. Proton pump inhibitor (PPI) therapy positive; 4. Aged between 18 and 65 years, Written informed consent

Exclusion criteria

Exclusion criteria: The inclusion criteria were as follows: Nasopharynx or upper esophagus obstruction; Esophageal varices and eophageal mucosal erosion; Severe esophageal motility disorder; In vivo with congenital gastrointestinal malformation, gastrointestinal obstruction, perforation, stricture or fistula; A recently history of stomach surgery,gastrointestinal bleeding (within the past six months); A history of bleeding tendency and taking anticoagulant drugs in long-term; Any implanted electrical device such as cardiac pacemakers; Allergy to the polymer materials; Various acute enteritis, severe ischemic disease and radioactive colitis; Pregnancy/lactation; Unstable cardiopathy, psychotic diseases, arrhythmia cordis, uncooperative.

Design outcomes

Primary

MeasureTime frame
esophageal pH value;The incidence of adverse reactions;the rate of capsule detachment spontaneousl;

Secondary

MeasureTime frame
success rate of capsule attachment;Tolerance evaluation;Symptoms during the period of capsule attachment;Symptoms during the period of capsule monitoring;Modifications of daily activity, diet and sleep with pH capsule;acceptance evaluation;

Countries

China

Contacts

Public ContactXiaoyan Zhao
zhaoxx@medmail.com.cn+86 13808395965

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026