COLOCAT study

JRCT ID: jRCTs042180142

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: The patient that a large intestine tumor, a polyp is doubted The patient who judged that there was t
• Date of first enrollment: 20/12/2014
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Device,equipment

Outcome(s)

• Primary Outcome: Sensitivity and specificity of colon capsule and CT colonography for colorectal tumors/polyps
• Secondary Outcome: Adverse events, examination time, compliance, and detection rates of colorectal tumors or polyps stratified by fetal hemoglobin concentration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with positive fecal immunological tests or symptoms suspicious of harboring colorectal tumors or polyps

Exclude 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

Related Information

• Primary Sponsor: Ohmiya Naoki