Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, 710032, China
NCT Number: NCT06922877
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope
endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope
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
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.
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
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
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-)
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
Xijing Hospital of Digestive Diseases
Other
Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy: a Single-center Randomized Controlled Trial
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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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