Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy

NCT06922877 | Completed DMC

• 1 other identifier: KY20242178-F-1
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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 procedures. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are: Does 3-dimensional (3D) imaging device improve the correct classification as well as size and depth evaluation of polyps and adenomas during colonoscopy using pathology as gold standard? What adverse events do participants experience during colonoscopy and polypectomy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve classification and evaluation accuracy. Participants will: Undertake colonoscopy examination and polypectomy using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.

Conditions

Colorectal Polyps; Colorectal Adenomas

Keywords

three dimension imaging device; colorectal polyps; colorectal adenomas

Outcome Measures

Primary Outcomes (1)

• Overall diagnostic accuracy of endoscopic polyp classification

  The overall proportion of correct classifications by endoscopy (JNET vs. JNET+3D) compared to the gold standard (pathology) at the lesion level, across all polyp types

  1-7 days after polypectomy

Secondary Outcomes (5)

• Diagnostic accuracy of endoscopic classification for advanced polyps

  1-7 days after polypectomy

• Diagnostic accuracy of endoscopic classification for serrated lesions

  1-7 days after polypectomy

• Diagnostic accuracy of endoscopic classification for identifying patients requiring surveillance

  1-7 days after polypectomy

• Diagnostic characteristics (sensitivity, specificity, PPV, NPV, LR+, LR-) for advanced polyps

  1-7 days after polypectomy

• The colonoscopy-relevant adverse events

  1-30 days after polypectomy

Study Arms (2)

2D imaging arm

ACTIVE COMPARATOR

participants will undergo polypectomy (CSP, CFP, or EMR) using 2D imaging colonoscope

Diagnostic Test: endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope

3D imaging arm

EXPERIMENTAL

participants will undergo polypectomy (CSP, CFP, or EMR) using 3D imaging colonoscope

Diagnostic Test: endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope

Interventions

endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope DIAGNOSTIC_TEST

endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope

2D imaging arm

endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope DIAGNOSTIC_TEST

endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope

3D imaging arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Study Officials

• Zhiguo Liu, M.D

  Xijing Hospital of Digestive DIsease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: October 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)