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Capsule gastric endoscopy for screening of gastric diseases in simulated home scenarios: a multicentre, prospective study

Capsule gastric endoscopy for screening of gastric diseases in simulated home scenarios: a multicentre, prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094581
Enrollment
Unknown
Registered
2024-12-25
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Chronic gastritis with erosion, Gastric ulcer, Gastric polyps, Gastric masses, Atrophy, Haemorrhage, Submucosal elevation or external compression, Fundal varices, Capillary dilatation, Significant bile reflux, Oesophageal mucosal lesions, Abnormal Mucosa, Simple chronic superficial gastritis, No detected lesions

Interventions

Intervention group:Examination with capsule gastric endoscopy, Examination with electronic gastroduodenoscopy

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Voluntary signed informed consent; 2. Age>=18, gender is not limited; 3.Voluntarily undergo electronic gastroscopy and capsule gastric endoscopy system according to the indications of electronic gastroscopy and capsule gastric endoscopy system. 4.Subjects were confirmed not to have high risk factors for gastrointestinal retention or obstruction by questionnaire survey.

Exclusion criteria

Exclusion criteria: 1.Pregnant women; 2.Presence of gastrointestinal retention or obstruction and other reasons why capsule gastric endoscopy system should not be performed; 3.Subjects who are unable to properly understand the physician's instructions during the examination and have poor objective cooperation; 4.Subjects who, in the judgement of the investigator, are considered unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Diagnostic concordance, positive concordance, negative concordance, positive predictive value, and negative predictive value between capsule gastric endoscopy and electronic gastroduodenoscopy;

Secondary

MeasureTime frame
Diagnostic consistency and mean diagnostic time between capsule gastric endoscopy image-assisted monitoring software and manual reading of films;Satisfaction evaluation of capsule gastric endoscopy;Evaluation of image quality of capsule gastric endoscopy;Overall coverage of gastric anatomy with capsule gastric endoscopy and electron gastroduodenoscopy;Evaluation of gastric filling degree and gastric cleanliness by capsule gastric endoscopy image-assisted monitoring software;Failure rate of capsule gastric endoscopic instruments;Examination completion rate, mean dwell time, mean examination time, 72-hour expulsion rate, and lesion detection rate of capsule gastric endoscopy;Gastric filling, gastric cleanliness, and visualization of gastric mucosa by capsule gastric endoscopy;Overall coverage of gastric wall maps/anatomical structures of the stomach in capsule-based gastric endoscopy image-assisted monitoring software;Incidence and severity of adverse events;

Countries

China

Contacts

Public ContactLiu Side

Nanfang Hospital, Southern Medical University

liuside@163.com+86 20 61641537

Outcome results

None listed

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