Colorectal AdenomaNCT06924489
Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy
A study testing Colonoscopy after bowel cleansing with 2D imaging device and Colonoscopy after bowel cleansing with 3D imaging device in people with Colorectal Adenoma and Colorectal Polyps, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Polyps
- What is being tested?
- Colonoscopy after bowel cleansing with 2D imaging device and Colonoscopy after bowel cleansing with 3D imaging device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,566 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hui Chen, M.D contact
About this study
Official title: Effect of 3-Dimensional Imaging Device on Advanced Adenoma Detection During Colonoscopy: A Multi-center Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Colorectal Adenoma, Colorectal Polyps
- Being tested
- Colonoscopy after bowel cleansing with 2D imaging device, Colonoscopy after bowel cleansing with 3D imaging device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy after bowel cleansing with 2D imaging deviceProcedure or surgery
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.
Colonoscopy after bowel cleansing with 3D imaging deviceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 2D imaging arm | Active comparator | participants will undergo colonoscopy examination using 2D imaging colonoscope Receives: Procedure: Colonoscopy after bowel cleansing with 2D imaging device |
| 3D imaging arm | Experimental | participants will undergo colonoscopy examination using 3D imaging colonoscope Receives: Procedure: Colonoscopy after bowel cleansing with 3D imaging device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-7 days after polypectomy
Secondary outcomes (13)
Adenoma detection rate (ADR)
The number of participants with at least 1 adenoma divided by the total number of participants
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 1-30 days after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, M.D, Principal investigator, Xijing Hospital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924489
- Sponsor's protocol ID
- KY20242132-F-1
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3-Dimensional Imaging Device on Advanced Adenoma Detection During Colonoscopy: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06924489
- Acronym / sponsor ID
- KY20242132-F-1
- Conditions
- Colorectal Adenoma, Colorectal Polyps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,566 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Qilu Hospital of Shandong University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D imaging arm | Active comparator | Procedure: Colonoscopy after bowel cleansing with 2D imaging deviceparticipants will undergo colonoscopy examination using 2D imaging colonoscope |
| 3D imaging arm | Experimental | Procedure: Colonoscopy after bowel cleansing with 3D imaging deviceparticipants will undergo colonoscopy examination using 3D imaging colonoscope |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy after bowel cleansing with 2D imaging deviceparticipants 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. | Procedure or surgery | 2D imaging arm |
| Colonoscopy after bowel cleansing with 3D imaging deviceparticipants 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. | Procedure or surgery | 3D imaging arm |
Primary outcome
High-risk adenoma (HRA) detection rate
Time frame: 1-7 days after polypectomy
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
13 secondary outcomes
Adenoma detection rate (ADR)
Time frame: 1-7 days after polypectomy
Polyp detection rate (PDR)
Time frame: 1-7 days after polypectomy
Clinically relevant serrated polyp detection rate
Time frame: 1-7 days after polypectomy
Modified advanced adenoma detection rate
Time frame: 1-7 days after polypectomy
Advanced adenocarcinoma detection rate
Time frame: 1-7 days after polypectomy
The number of lesions per colonoscopy
Time frame: 1-7 days after polypectomy
Lesion detection rate in different location
Time frame: 1-7 days after polypectomy
Lesion detection rate in different size
Time frame: 1-7 days after polypectomy
Lesion detection rate in different type
Time frame: 1-7 days after polypectomy
Lesion detection rate by endoscopists of different experience
Time frame: 1-7 days after polypectomy
Cecal intubation time
Time frame: immediately during the colonoscopy examination procedure
Withdrawal time
Time frame: immediately during the colonoscopy examination procedure
The colonoscopy-relevant adverse events
Time frame: 1-30 days after polypectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Chen, M.D contact
Zhiguo Liu, M.D principal investigator
Xijing Hospital of Digestive Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy after bowel cleansing with 2D imaging device and Colonoscopy after bowel cleansing with 3D imaging device in people with Colorectal Adenoma and Colorectal Polyps, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhiguo Liu, M.D (86-29-84771535, liuzhiguo@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-risk adenoma (HRA) detection rate (time frame: 1-7 days after polypectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.