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

  1. Aged 18 years or older.

  2. 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.

  3. Willing to participate voluntarily in the clinical trial and provide written informed consent.

  4. Capable of communicating with researchers and complying with trial requirements.

Exclusion criteria

  1. Pregnant individuals.
  2. 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.
  3. Individuals with swallowing dysfunction.
  4. Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
  5. Participants who are unable to comprehend and/or comply with physician instructions during the examination.
  6. 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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Page 1 of 3 (12 locations)

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