Subjects who have a history of receiving a colon endoscope test within the last 3 months and who are known to have a lesion for which endoscopic or surgical treatment is necessary according to a colon endoscope test result findings report in which all observed lesions were noted
Conditions
Interventions
Oral ingestion of PC2-101
Sponsors
Given Imaging K.K.
National Cancer Center Hospital Jikei University School of Medicine Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Over 18 years old-individuals who have known lesions detected by Colonoscopy within the last 3 months before the screening day. (2) Individuals who can receive Colon Capsule Endoscopy within 1 month after the screening day. (3) Individuals with written informed consent
Exclusion criteria
Exclusion criteria: Individuals 1. who have dysphasia 2. who have known or suspected occlusion, stenosis, or a fistula of the digestive tract in abdominal x-ray test, abdominal ultrasound test, in their medical/ surgical history, in their clinical findings, or the like (this excludes cases where determination was not possible using the methods indicated above, but possible to confirm the absence of stenosis in small intestine double contrast testination including simple method) 3. who received radiological treatment of the pelvic viscera and with suspected stenosis due to radiological enterocolitis 4. who have a history of surgical procedure within the abdominal cavity (e.g. colostomy procedure or bypass procedure) and for whom the absence of any problem in carrying out the present investigation cannot be confirmed with appropriate test including small bowel test 5. who have embedded electrical endoscopic or surgical device, e.g. a cardiac pacemaker 6. with scheduled MRI test 7. with known gastrointestinal motility function disorder that makes it difficult to carry out this study 8. with known delayed gastric emptying that makes it difficult to carry out this study 9. with history of long-term administration of NSAIDs and with suspected of having a stenosis due to bowel disease caused by the NSAIDs 10. with a serious heart condition 11. with any type of allergy or warning/contraindication against the drugs to be used in this study 12. who are/may be pregnant or breastfeeding, 13. whose clinical condition may not enable to carry out required items from the study protocol or that may limit participation in the study 14. with fatal conditions 15. with lesions for which surgical treatment is necessary, and which may become advanced rapidly. 16. with scheduled participation in other clinical studies during the clinical study duration. 17. who clinical study principal investigator, or subinvestigator has determined are not suitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether the objectives of the examination are achieved or not | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactTomoya Kamei
Given Imaging K.K. Regulatory & Clinical Affairs, QA/QC Dpt.
Outcome results
None listed