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Combined use of mucosal exposure devices and computer-assisted detection in improving adenoma miss rate: a back-to-back colonoscopy-based, multicenter, randomized controlled trial

Combined use of mucosal exposure devices and artificial intelligence in improving adenoma miss rate: a back-to-back colonoscopy-based, multicenter, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083653
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-05-09
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

precancerous lesion of the colon

Interventions

Mucosal exposure device + AI-AI group:Subjects were subjected to back-to-back colonoscopy with the first observation using a mucosal exposure device + AI-assisted colonoscopy, and a second observation
AI- AI+ Mucosal Exposure Device group:Subjects were subjected to back-to-back colonoscopies with the first observation using a AI-assisted colonoscope and a second observation using a mucosal exposure

Sponsors

Shanghai tenth people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Male or female, aged 45–75 years. 2) Individuals undergoing colorectal cancer screening. 3) Self-evaluated good bowel preparation (watery stool without residue or clear liquid stool). 4) Willing to participate in this clinical trial and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients suspected or confirmed to have colorectal cancer based on imaging, laboratory tests (CEA > 20 ng/ml), or clinical findings (e.g., palpable abdominal mass, positive digital rectal examination, unexplained weight loss, or anemia). 2) Patients with abnormal blood coagulation, or those who have taken antiplatelet or anticoagulant agents within the past 7 days. 3) Patients with inflammatory bowel disease or polyposis syndromes. 4) History of colectomy or abdominal surgery. 5) Patients with severe comorbidities or other high-risk conditions who cannot tolerate endoscopic examination. 6) Patients who refuse to sign the informed consent form, or any other condition deemed inappropriate for enrollment or that may affect participation in the study. Exclusion After Enrollment (Elimination Criteria) 1) Patients in whom colonoscope insertion is difficult (initial insertion time > 7 minutes). 2) Poor bowel preparation (any bowel preparation score < 2). 3) Patients requiring withdrawal of the mucosal exposure device during colonoscopy.

Design outcomes

Primary

MeasureTime frame
adenoma miss rate;

Secondary

MeasureTime frame
polyp miss rate ;sessile serrated lesion miss rate;

Countries

china

Contacts

Public Contactliu feng

Shanghai tenth people's hospital

drliuffeng@hotmail.com+86 21 8197 3214

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026