COLOCAT study

Phase 4

• Conditions: The patient that a large intestine tumor, a polyp is doubted The patient who judged that there was t

• Registration Number: JPRN-jRCTs042180142
• Lead Sponsor: Ohmiya Naoki

Brief Summary

Both examinations showed high detectability for colorectal tumors and polyps, but the colon capsule endoscopy group showed higher detectability for flat polyps than CT colonography.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Patients with positive fecal immunological tests or symptoms suspicious of harboring colorectal tumors or polyps

Exclusion Criteria

1. Patients with dysphasia
2. Patients with drug allergy used in this study.
3. Pregnant or possible pregnant women
4. Patients who will undergo MRI 2weeks after colon capsule endoscopy
5. Patients with present or past history of small and large bowel obstruction
6. Patients suspicious of having colorectal advanced carcinoma by tumor markers or symptoms
7. Patients inappropriate for this study by other reasons judged by investigators
8. When it is inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of colon capsule and CT colonography for colorectal tumors/polyps

Secondary Outcome Measures

Name	Time	Method
Adverse events, examination time, compliance, and detection rates of colorectal tumors or polyps stratified by fetal hemoglobin concentration