Using 3D imaging to improve colon polyp and adenoma classification during colonoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a 3-dimensional (3D) imaging device in accurately classifying colorectal polyps and adenomas during colonoscopy. Participants will undergo colonoscopy procedures using either the 3D imaging device or a traditional 2-dimensional (2D) imaging device, with the goal of determining if the 3D device enhances classification accuracy and evaluation of polyp size and depth. The study will also assess the safety of the 3D imaging device by monitoring any adverse events that occur during the procedures. Follow-up will occur for 30 days post-procedure to track any potential complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged over 18 years;
* Endoscopically diagnosed with colorectal polyps;
* Signing the written informed consent.

Exclusion Criteria:

* 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.

Where it's running

• Xijing Hospital of Digestive Disease
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Zhiguo Liu, M.D — Xijing Hospital of Digestive DIsease
• Study coordinator: Zhiguo Liu, M.D
• Email: liuzhiguo@fmmu.edu.cn
• Phone: 86-29-84771535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.