3D imaging during colonoscopy to find high-risk adenomas

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

Participants undergo colonoscopy with either a 3D imaging device or the standard 2D imaging device after bowel cleansing, and are followed for up to 30 days to monitor adverse events. The study compares the 3D approach to the traditional method to see if it improves detection of high-risk adenomas. Safety and feasibility of 3D imaging during colonoscopy are also evaluated. Eligible adults are undergoing diagnostic colonoscopy without prior colorectal disease or certain polyposis conditions. The trial is conducted at Xijing Hospital with collaboration from Beijing Friendship Hospital and Qilu Hospital of Shandong University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Xijing Hospital
  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.