Status:
RECRUITING
Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Fondazione Poliambulanza Istituto Ospedaliero
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
Gastric Lesion
Gastritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the diagnostic accuracy of the AI-integrated Capsule Gastroscopy (ACG) system in simulated home-use conditions for detecting upper gastrointestinal (UGI)...
Detailed Description
Gastroscopy stands as the gold standard for diagnosis of upper gastrointestinal (UGI) diseases (1, 2). However, China faces a significant challenge due to its large population base and an insufficient...
Eligibility Criteria
Inclusion criteria
-
Aged 18 years or older.
-
Individuals meeting the following criteria:
i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.
-
Willing to participate voluntarily in the clinical trial and provide written informed consent.
-
Capable of communicating with researchers and complying with trial requirements.
Exclusion criteria
- Pregnant individuals.
- Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.
- Individuals with swallowing dysfunction.
- Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
- Participants who are unable to comprehend and/or comply with physician instructions during the examination.
- Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT06848400
Start Date
March 3 2025
End Date
December 31 2026
Last Update
July 9 2025
Active Locations (12)
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1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510515
2
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510515
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
4
Renhua People's Hospital
Shaoguan, Guangdong, China, 510515