Status:
RECRUITING
Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Colorectal Polyps
Colorectal Adenomas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to correctly classify colon polyps and adenomas during colonoscopy to guide the selection of proper treatment pro...
Eligibility Criteria
Inclusion
- Aged over 18 years;
- Endoscopically diagnosed with colorectal polyps;
- Signing the written informed consent.
Exclusion
- Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
- Patients with severe cardiopulmonary insufficiency;
- Patients with severe coagulation disorders or high bleeding risk (platelets \<50×10⁹/L, INR \>1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
- Patients with severe electrolyte imbalances;
- Patients with acute peritonitis or suspected intestinal perforation;
- Patients with severe inflammatory bowel disease/toxic megacolon;
- Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \[FAP\], Lynch syndrome, etc.);
- Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- Patients with untreated severe abdominal hernia, intestinal obstruction, or advanced colorectal cancer;
- Patients with intestinal strictures of any cause;
- Cases requiring only endoscopic submucosal dissection (ESD);
- Pregnancy and lactation.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06922877
Start Date
April 8 2025
End Date
January 31 2026
Last Update
April 24 2025
Active Locations (1)
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1
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China, 710032