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A multicenter prospective randomized controlled trial evaluating the usefulness of a real-time colonoscopy diagnostic support system

A multicenter prospective randomized controlled trial evaluating the usefulness of a real-time colonoscopy diagnostic support system - eardrum study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051437
Enrollment
620
Registered
2023-06-25
Start date
2023-06-26
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

Colorectal Neoplasms

Interventions

Using an AI system during colonoscopy. Do not use an AI system during colonoscopy.

Sponsors

Toho University Oomori hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who undergo colonoscopy 2) Age:35 to 75 (at the registry) 3) Patients who can follow Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment 4) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who underwent total colonoscopy within 2 years (24 months) 2) Patients with prior colectomy other than appendectomy 3) GI polyposis 4) Patients with complications, such as chronical hematological disease 5) Patients with active inflammatory bowel diseases, such as ulcerative colitis or Crohn's disease 6) pregnant patient

Design outcomes

Primary

MeasureTime frame
Adenoma Detection Rate

Secondary

MeasureTime frame
1 ) Polyp Detection Rate 2 ) Adenoma per Positive Colonoscopy 3 ) Rate of increase in ADR by colonoscopy experience 4 ) Detection rate by lesion (size (6 mm or more, less than 6 mm), macroscopic type, location) 5 ) Sessile Serrated Lesion detection rate 6 ) Total procedure time

Countries

Japan

Contacts

Public ContactYusuke Nishikawa

Toho University Oomori hospital Departments of Gastroenterology

yuusuke.nishikawa@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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