Status:
NOT_YET_RECRUITING
Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Collaborating Sponsors:
Beijing Friendship Hospital
Qilu Hospital of Shandong University
Conditions:
Colorectal Adenoma
Colorectal Polyps
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also ...
Eligibility Criteria
Inclusion
- Aged 18-75 years;
- Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
- Signing the written informed consent;
Exclusion
- Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \[FAP\], Lynch syndrome, etc.);
- Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
- Patients with a history of colorectal adenocarcinoma or alarming symptoms;
- Patients with a history of inflammatory bowel disease;
- 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 toxic megacolon;
- 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;
- Patients with intestinal strictures of any cause;
- Pregnancy and lactation.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
1566 Patients enrolled
Trial Details
Trial ID
NCT06924489
Start Date
June 1 2025
End Date
July 1 2026
Last Update
April 11 2025
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