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OpenTrials
Completed

NCT Number: NCT06922877

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Overall diagnostic accuracy of endoscopic polyp classification

    Time frame: 1-7 days after polypectomy

    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

Secondary outcomes

  1. Diagnostic accuracy of endoscopic classification for advanced polyps

    Time frame: 1-7 days after polypectomy

    The overall proportion of correct classifications by endoscopy compared to the gold standard (pathology) in lesion level about advanced polyps Advanced polyp was defined as having a conventional adenoma with size ≥10 mm or with high-grade dysplasia, or a sessile serrated lesion with size ≥10 mm or with dysplasia.

  2. Diagnostic accuracy of endoscopic classification for serrated lesions

    Time frame: 1-7 days after polypectomy

    The overall proportion of correct classifications by endoscopy (JNET vs. JNET+3D) compared to the gold standard (pathology) at the lesion level for serrated lesions

  3. Diagnostic accuracy of endoscopic classification for identifying patients requiring surveillance

    Time frame: 1-7 days after polypectomy

    patients with complete removal of at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia

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

    Time frame: 1-7 days after polypectomy

    The following diagnostic accuracy measures will be calculated for endoscopic classification (JNET vs. JNET+3D) in detecting adenomas at the lesion level, using final pathology as the gold standard:

    Sensitivity Specificity Positive predictive value (PPV) Negative predictive value (NPV) Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)

  5. The colonoscopy-relevant adverse events

    Time frame: 1-30 days after polypectomy

    aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy: a Single-center Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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