Colon AdenomasNCT07308743
Impact of Computer-aided Detection System on the Right Colon Adenoma Miss Rate
A study testing Computer-aided detection-assisted colonoscopy and Conventional white-light colonoscopy in people with Colon Adenomas and Colon Polyps, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Adenomas, Colon Polyps, Sessile Serrated Lesion
- What is being tested?
- Computer-aided detection-assisted colonoscopy and Conventional white-light colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 12 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age 40-75 years old, regardless of gender
- Patients presenting for physical examination, colorectal cancer screening or diagnosis
- Patients voluntarily signs an informed consent form
Who cannot join
- Unable to cooperate ot tolerate colonoscopy
- History of inflammatory bowel disease
- History of colorectal cancer
- Previous colorectal surgery
- History of recurrent constipation
- Taking anticoagulant and antiplatelet drugs berfore procedure
- High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
- Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Impact of Computer-aided Detection System on the Right Colon Adenoma Miss Rate: a Multicenter Tandem Rondomized Controlled Trial
This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.
Read the detailed description
This is a prospective, multicenter, tandem randomized controlled trial conducted at 8 endoscopy centers in China (Guangdong). Participants are randomized at a 1:1 ratio to undergo either CADe-assisted colonoscopy first or conventional white-light colonoscopy first. The second colonoscopy is performed immediately afterward in tandem fashion by the same endoscopist.
A variable-block randomization design with block sizes ranging from 4 to 6 was adopted. The random sequence was generated in advance by the lead center using a digital random number generator to allocate participants to study groups. After successful cecal intubation and confirmation of adequate right sided bowel cleaning, the performing operator was informed of the group allocation by the trained research assistants. All participants, pathologists, and statisticians remained blinded to group allocation throughout the study.
- Conditions
- Colon Adenomas, Colon Polyps, Sessile Serrated Lesion
- Being tested
- Computer-aided detection-assisted colonoscopy, Conventional white-light colonoscopy
- Keywords
- computer-aided detection, proximal adenoma miss rate, Randomized Tandem Colonoscopy Study
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-aided detection-assisted colonoscopyDevice
Computer-aided detection-assisted colonoscopy for detection of colonic polyp
Conventional white-light colonoscopyProcedure or surgery
Conventional white-light colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Computer-aided detection-assisted colonoscopy | Experimental | Tandem colonoscopy of proximal colon assisted with computer-aided detection system followed by conventional white-light colonoscopy Receives: Device: Computer-aided detection-assisted colonoscopy |
| Conventional white-light colonoscopy | Active comparator | Tandem conventional white-light colonoscopy of proximal colon followed by usual computer-aided detection-assisted colonoscopy Receives: Procedure: Conventional white-light colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right adenoma missed rate
The number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection.
Measured: At the time of index tandem colonoscopy
Secondary outcomes (4)
Right polyp missed rate
The number of polyps identified during the second right colon inspection divided by the overall number of polyps identified during the first and second right colon inspection.
Measured: At the time of index tandem colonoscopy
Right serrated polyp missed rate
The number of serrated polyp identified during the second right colon inspection divided by the overall number of serrated polyp identified during the first and second right colon inspection.
Measured: At the time of index tandem colonoscopy
Right SSLs missed rate
The number of SSLs identified during the second right colon inspection divided by the overall number of SSLs identified during the first and second right colon inspection.
Measured: At the time of index tandem colonoscopy
Right advanced adenoma missed rate
The number of advanced adenomas identified during the second right colon inspection divided by the overall number of advanced adenomas identified during the first and second right colon inspection.
Measured: At the time of index tandem colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start25 Dec 2025
- Primary completion5 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomasStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Model description
- Prospective randomized design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Fifth Affiliated Hospital of Zunyi Medical College, Longgang District People's Hospital of Shenzhen, Yangjiang People's Hospital, Jiangmen Central Hospital, Dongguan Shuixiang Central Hospital, Pingshan District People's Hospital of shenzhen, The Third People's Hospital of Huizhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308743
- Sponsor's protocol ID
- NFEC-2025-679
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computer-aided Detection System on the Right Colon Adenoma Miss Rate: a Multicenter Tandem Rondomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07308743
- Acronym / sponsor ID
- NFEC-2025-679
- Conditions
- Colon Adenomas, Colon Polyps, Sessile Serrated Lesion
- Keywords
- computer-aided detection, proximal adenoma miss rate, Randomized Tandem Colonoscopy Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- The Fifth Affiliated Hospital of Zunyi Medical College, Longgang District People's Hospital of Shenzhen, Yangjiang People's Hospital, Jiangmen Central Hospital, Dongguan Shuixiang Central Hospital, Pingshan District People's Hospital of shenzhen, The Third People's Hospital of Huizhou
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 30 Dec 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.
This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.
Detailed description
This is a prospective, multicenter, tandem randomized controlled trial conducted at 8 endoscopy centers in China (Guangdong). Participants are randomized at a 1:1 ratio to undergo either CADe-assisted colonoscopy first or conventional white-light colonoscopy first. The second colonoscopy is performed immediately afterward in tandem fashion by the same endoscopist.
A variable-block randomization design with block sizes ranging from 4 to 6 was adopted. The random sequence was generated in advance by the lead center using a digital random number generator to allocate participants to study groups. After successful cecal intubation and confirmation of adequate right sided bowel cleaning, the performing operator was informed of the group allocation by the trained research assistants. All participants, pathologists, and statisticians remained blinded to group allocation throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized design
| Arm | Type | Receives |
|---|---|---|
| Computer-aided detection-assisted colonoscopy | Experimental | Device: Computer-aided detection-assisted colonoscopyTandem colonoscopy of proximal colon assisted with computer-aided detection system followed by conventional white-light colonoscopy |
| Conventional white-light colonoscopy | Active comparator | Procedure: Conventional white-light colonoscopyTandem conventional white-light colonoscopy of proximal colon followed by usual computer-aided detection-assisted colonoscopy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age 40-75 years old, regardless of gender
- Patients presenting for physical examination, colorectal cancer screening or diagnosis
- Patients voluntarily signs an informed consent form
Key exclusion criteria (8 listed)
- Unable to cooperate ot tolerate colonoscopy
- History of inflammatory bowel disease
- History of colorectal cancer
- Previous colorectal surgery
- History of recurrent constipation
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 |
|---|---|---|
| Computer-aided detection-assisted colonoscopyComputer-aided detection-assisted colonoscopy for detection of colonic polyp | Device | Computer-aided detection-assisted colonoscopy |
| Conventional white-light colonoscopyConventional white-light colonoscopy | Procedure or surgery | Conventional white-light colonoscopy |
Primary outcome
Right adenoma missed rate
Time frame: At the time of index tandem colonoscopy
The number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection.
4 secondary outcomes
Right polyp missed rate
Time frame: At the time of index tandem colonoscopy
Right serrated polyp missed rate
Time frame: At the time of index tandem colonoscopy
Right SSLs missed rate
Time frame: At the time of index tandem colonoscopy
Right advanced adenoma missed rate
Time frame: At the time of index tandem colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-aided detection-assisted colonoscopy and Conventional white-light colonoscopy in people with Colon Adenomas and Colon Polyps, run by Nanfang Hospital, Southern Medical University 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 8 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: finished, as of the sponsor's last update on 22 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right adenoma missed rate (time frame: At the time of index tandem colonoscopy). 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 22 Oct 2026.