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Clinical usefulness of second generation colon capsule endoscopy (CCE-2) in patients with ulcerative colitis

Clinical usefulness of second generation colon capsule endoscopy (CCE-2) in patients with ulcerative colitis - Clinical usefulness of colon capsule endoscopy in patients with ulcerative colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000030539
Enrollment
50
Registered
2017-12-24
Start date
2015-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with ulcerative colitis

Interventions

None listed

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with known ulcerative colitis Category A: outpatient, in clinical remission defined as the Rachmilewitz index of 0-4 points Category B: active inpatient 2. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with dysphagia 2. Pregnant or possible pregnant women 3. Patients with a pacemaker or other implanted electromedical device 4. Patients with present or past history of small and large bowel obstruction 5. Patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition) 6. Patients with an allergy to polyethylene glycol, magnesium citrate, sennoside, metoclopramide or mosapride citrate 7. Patients who will undergo MRI 2 weeks after CCE 8. Patients inappropriate for this study by other reasons judged by investigators

Design outcomes

Primary

MeasureTime frame
1. The rate of total colon observation within its battery life, and transit time 2. Severity of mucosal inflammation in clinical remission assessed by CCE using Mayo endoscopic subscore (Mayo ES) and Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

Secondary

MeasureTime frame
1. Cleansing level with a 4-point grading scale (poor, fair, good, and excellent) 2. Adverse events 3. Relapse-free survival, Exacerbation-free survival, surgery-free survival 4. Acceptability of CCE assessed by questionnaire survey.

Countries

Japan

Contacts

Public ContactSatoshi Osawa

Hamamatsu University School of Medicine Department of Endoscopic and Photodynamic Medicine

sososawa@hama-med.ac.jp+81-53-435-2261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026