UMIN ID: UMIN000048393
Registered date:31/07/2022
X1 study
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Colon polyp |
| Date of first enrollment | 2022/08/01 |
| Target sample size | 350 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Endoscopic magnified observation with NBI |
Outcome(s)
| Primary Outcome | The sensitivity for pT1b cancer in Dual-Focus and Full-Zoom magnified NBI endoscopy |
|---|---|
| Secondary Outcome | The concordance between the histology and magnified NBI findings according to Japan NBI expert Team (JNET) cllasification |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Cases with inflammatory bowel disease or with polyposis syndrome 2. Cases with blood coagulation dysfunction or with unavailable suspension of anticoagulants 3. Cases deemed unsuitable as a subject in the study by the investigator for some other reason |
Related Information
| Primary Sponsor | Division of Endoscopy, Shizuoka Cancer Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kenichiro Imai |
| Address | 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan Japan 411-8777 |
| Telephone | 055-989-5222 |
| ke.imai@scchr.jp | |
| Affiliation | Shizuoka Cancer Center Division of Endoscopy |
| scientific contact | |
| Name | Kenichiro Imai |
| Address | 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan Japan |
| Telephone | 055-989-5222 |
| ke.imai@scchr.jp | |
| Affiliation | Shizuoka Cancer Center Division of Endoscopy |