Multicenter study of capsule endoscopy at home

JRCT ID: jRCTs042220163

Registered date:24/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ulcerative colitis, small bowel diseases
• Date of first enrollment: 24/03/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): To have a capsule endoscopy

Outcome(s)

• Primary Outcome: Completion rate in capsule endoscopy at home

Secondary Outcome

1)Adverse event:Stasis,Deglutition impossibility,
Misswallowing,Abdominalgia,Vomition,Intestinal
obstruction etc.,Malfunction
2)Entire small intestinal observation rate/Entire
colon observation rate/Lesion detection rate
3)Satisfaction

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

Patients who have received sufficient explanation before participating in this study, and have
obtained written consent by their own free will
with sufficient understanding.
Patients aged between 18 and 65 at the time of
consent.
Colon capsule endoscopy: fecal immunochemical test-positive,screening for colorectal cancer,
ulcerative colitis
Small bowel capsule endoscopy: all small bowel
diseases or suspected disease without the
passage test by the patency capsule

Exclude criteria

1.People who have previously undergone capsule endoscopy
2.Crohn's disease
3.After gastrointestinal surgery
4.After abdominal radiotherapy
5.Long-term use of nonsteroidal anti-inflammatory drug
6.Stenosis or suspected stenosis of the digestive
tract
7.History of intestinal obstruction
8.Severe constipation
9.Active gastrointestinal bleeding
10.Cardiac hypertrophy
11.Systemic scleroderma
12. Patients in whom pacemaker or other medical devices are implanted
13. Dysplasia
14. Any other unsuitable conditions found by a
doctor

Related Information

• Primary Sponsor: Ohmiya Review Naoki
• Source(s) of Monetary Support: The Japanese Association for Capsule Endoscopy