An interventional study of Colonoscopy after bowel cleansing with 2D imaging device and Colonoscopy after bowel cleansing with 3D imaging device in Colorectal Adenoma and Colorectal Polyps, sponsored by Xijing Hospital of Digestive Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Xijing Hospital of Digestive Diseases · Not applicable, Interventional, and Diagnostic
The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. 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 identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? 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 high risk adenoma identification.
Participants will:
Undertake colonoscopy examination 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.
312 studies on the registry are indexed under Polyps; 60 are open to participants now.
This study's planned enrollment of 1,566 is above the median of 150 across 204 interventional studies indexed under Polyps.
Browse Polyps studies →Xijing Hospital of Digestive Diseases is the lead sponsor of 81 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants will undergo colonoscopy examination using 2D imaging colonoscope
Procedure: Colonoscopy after bowel cleansing with 2D imaging device
participants will undergo colonoscopy examination using 3D imaging colonoscope
Procedure: Colonoscopy after bowel cleansing with 3D imaging device
participants will undergo colonoscopy examination using 2D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.
participants will undergo colonoscopy examination using 3D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.
High-risk adenoma (HRA) detection rate
HRA were defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs) or 5. ≥ 3 adenomas. SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance. HRA detection rate is defined as the number of participants diagnosed with HRA divided by the total number of participants
Time frame: 1-7 days after polypectomy
Adenoma detection rate (ADR)
The number of participants with at least 1 adenoma divided by the total number of participants
Time frame: 1-7 days after polypectomy
Polyp detection rate (PDR)
The number of participants with at least 1 polyp divided by the total number of participants
Time frame: 1-7 days after polypectomy
Clinically relevant serrated polyp detection rate
Clinically relevant serrated polyps are defined as ≥10 mm serrated polyps (SPs, including hyperplastic polyps, SSLs, and traditional serrated adenomas) and \>5 mm SPs in the proximal colon. Clinically relevant serrated polyp detection rate is defined as the number of participants with at least 1 clinically relevant serrated polyp divided by the total number of participants.
Time frame: 1-7 days after polypectomy
Modified advanced adenoma detection rate
Modified advanced adenoma are defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs). SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance. Modified advanced adenoma detection rate is defined as the number of participants diagnosed with modified advanced adenoma divided by the total number of participants
Time frame: 1-7 days after polypectomy
Advanced adenocarcinoma detection rate
Advanced adenocarcinoma is defined as adenocarcinoma with submucosal invasion more than 1000μm (SM2). Advanced adenocarcinoma detection rate is defined as the number of participants diagnosed with advanced adenocarcinoma divided by the total number of participants
Time frame: 1-7 days after polypectomy
The number of lesions per colonoscopy
The number of lesions per colonoscopy was defined as the number of corresponding lesions (adenoma, polyp, clinically relevant serrated polyps, et al)divided by the total number of colonoscopies or participants
Time frame: 1-7 days after polypectomy
Lesion detection rate in different location
Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different location of colon and rectum
Time frame: 1-7 days after polypectomy
Lesion detection rate in different size
Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different size (≤3mm, 3-10mm, \>10mm)
Time frame: 1-7 days after polypectomy
Lesion detection rate in different type
Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different type (Paris classification)
Time frame: 1-7 days after polypectomy
Lesion detection rate by endoscopists of different experience
Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate by endoscopists of different experience (senior or junior)
Time frame: 1-7 days after polypectomy
Cecal intubation time
Cecal intubation time (CIT) is defined as the time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base or cecal end
Time frame: immediately during the colonoscopy examination procedure
Withdrawal time
Withdrawal time is defined as the time from reaching the cecal base or cecal end to the endoscope withdrawal to the anal verge, excluding the time of polypectomy
Time frame: immediately during the colonoscopy examination procedure
The colonoscopy-relevant adverse events
Aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy
Time frame: 1-30 days after polypectomy
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 68 non-industry interventional studies with no phase under Polyps, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 18 months is below that.
Counting every sponsor, half of 79 studies reached it within 23 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Xijing Hospital of Digestive Diseases