Study of usability of Gastrointestinal Endoscopy with a Single-Use Endoscope

Phase 2

Recruiting

• Conditions: Persons undergoing upper gastrointestinal endoscopy for suspected gastric cancer or other diseases; gastric cancer; D013274

• Registration Number: JPRN-jRCT1032230493
• Lead Sponsor: Matsumura Tomoaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-06
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients undergoing upper gastrointestinal endoscopy at this hospital are eligible for the following

1) Adults who are at least 18 years old and less than 90 years old at the time of consent
2) Patients scheduled to undergo upper gastrointestinal endoscopy
3) Patients who have been fully informed of the study, fully understand it, and have given their free and voluntary written consent to participate in the study.

Exclusion Criteria

Persons who meet any of the following conditions at the time of obtaining consent are not eligible
1) Those who do not intend to evaluate the stomach during the endoscopy
2) Those who are unable or unwilling to consent to sedation during the endoscopy
3) Patients for whom two or more upper gastrointestinal endoscopic examinations are considered inappropriate.
4) Pregnant, possibly pregnant, or within 28 days postpartum
5) Other patients who are deemed inappropriate for the safe conduct of this study by the Principal Investigator or the Principal Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement rate for diagnosis of gastric cancer (presence or absence and location of gastric cancer)

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoints<br>The concordance rate between the boundary of atrophic gastritis and the diagnosis based on the Kimura-Takemoto classification.<br>Agreement rate of endoscopic diagnosis of gastritis<br>The concordance rate of the presence or absence of lesions other than carcinoma.<br><br>Secondary safety endpoints<br>Complications (incidentalities)