JRCT ID: jRCT1032230493
Registered date:06/12/2023
Study of usability of Gastrointestinal Endoscopy with a Single-Use Endoscope
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Persons undergoing upper gastrointestinal endoscopy for suspected gastric cancer or other diseases |
| Date of first enrollment | 06/12/2023 |
| Target sample size | 12 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Observation of the stomach with a single-use endoscope before performing a previously scheduled reuse-endoscopy |
Outcome(s)
| Primary Outcome | Agreement rate for diagnosis of gastric cancer (presence or absence and location of gastric cancer) |
|---|---|
| Secondary Outcome | Secondary efficacy endpoints The concordance rate between the boundary of atrophic gastritis and the diagnosis based on the Kimura-Takemoto classification. Agreement rate of endoscopic diagnosis of gastritis The concordance rate of the presence or absence of lesions other than carcinoma. Secondary safety endpoints Complications (incidentalities) |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 90age old |
| Gender | Both |
| Include 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. |
| Exclude 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. |
Related Information
| Primary Sponsor | Matsumura Tomoaki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Clinical Research Initiation-Fund (of Chiba University Hospital) |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Mai Fujie |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN Chiba Japan 260-8677 |
| Telephone | +81-43-222-7171 |
| fujiemai@chiba-u.jp | |
| Affiliation | Chiba University Hospital |
| Scientific contact | |
| Name | Tomoaki Matsumura |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN Chiba Japan 260-8677 |
| Telephone | +81-43-222-7171 |
| matsumura@chiba-u.jp | |
| Affiliation | Chiba University Hospital |