Colorectal AdenomaNCT07097350
Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas
A study testing computer-aided detection alone and transparent cap-assisted colonoscopy combined with computer-aided detection in people with Colorectal Adenoma, run by Fudan University at 1 site in China.
Trial summary
A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- computer-aided detection alone and transparent cap-assisted colonoscopy combined with computer-aided detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2027
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 45-75 years
Who cannot join
- Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps
- Patients with highly suspected or pathologically confirmed colorectal cancer
- Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
- Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome
Show all 12Show fewer
- Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders
- Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days
- Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum
- A Boston Bowel Preparation Scale (BBPS) score < 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing)
- Use of non-guideline-recommended bowel preparation agents
- Patients undergoing emergency colonoscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
Danian Ji, M.D., +86-18019094606, arctg4@163.com
Zhiyu Dong, M.D., +86-18817870866, 18817870866@163.com
About this study
Official title: Study on the Effect of Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas
A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate
Read the detailed description
- Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection.
- Collecting variables which consist of primary and secodary outcomes.
- Conditions
- Colorectal Adenoma
- Being tested
- computer-aided detection alone, transparent cap-assisted colonoscopy combined with computer-aided detection
- Keywords
- transparent cap, computer-aided detection, adenoma detection rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-aided detection aloneDevice
colonoscopy with computer-aided detection
transparent cap-assisted colonoscopy combined with computer-aided detectionDevice
transparent cap-assisted colonoscopy combined with computer-aided detection
| Study group | Role | What they receive |
|---|---|---|
| computer-aided detection alone | Active comparator | colonoscopy with computer-aided detection alone Receives: Device: computer-aided detection alone |
| transparent cap-assisted colonoscopy combined with computer-aided detection | Experimental | transparent cap-assisted colonoscopy combined with computer-aided detection Receives: Device: transparent cap-assisted colonoscopy combined with computer-aided detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: 2 weeks after the procedure
Secondary outcomes (6)
sessile serrated lesion detection rate
Measured: 2 weeks after the procedure
advanced adenoma detection rate
Measured: 2 weeks after the procedure
polyp detection rate
Measured: 2 weeks after the procedure
Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate
CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis
Measured: immediately after the procedure
Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate
CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
Measured: 2 weeks after the procedure
perforation rate
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (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.
- More trials run by Fudan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Danian Ji, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097350
- Sponsor's protocol ID
- 2025K239
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT07097350
- Acronym / sponsor ID
- 2025K239
- Conditions
- Colorectal Adenoma
- Keywords
- transparent cap, computer-aided detection, adenoma detection rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 31 Jul 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.
A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate
Detailed description
- Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection.
- Collecting variables which consist of primary and secodary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer-aided detection alone | Active comparator | Device: computer-aided detection alonecolonoscopy with computer-aided detection alone |
| transparent cap-assisted colonoscopy combined with computer-aided detection | Experimental | Device: transparent cap-assisted colonoscopy combined with computer-aided detectiontransparent cap-assisted colonoscopy combined with computer-aided detection |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 45-75 years
Key exclusion criteria (12 listed)
- Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps
- Patients with highly suspected or pathologically confirmed colorectal cancer
- Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
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 alonecolonoscopy with computer-aided detection | Device | computer-aided detection alone |
| transparent cap-assisted colonoscopy combined with computer-aided detectiontransparent cap-assisted colonoscopy combined with computer-aided detection | Device | transparent cap-assisted colonoscopy combined with computer-aided detection |
Primary outcome
adenoma detection rate
Time frame: 2 weeks after the procedure
6 secondary outcomes
sessile serrated lesion detection rate
Time frame: 2 weeks after the procedure
advanced adenoma detection rate
Time frame: 2 weeks after the procedure
polyp detection rate
Time frame: 2 weeks after the procedure
Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate
Time frame: immediately after the procedure
Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate
Time frame: 2 weeks after the procedure
perforation rate
Time frame: immediately after the procedure
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 31 Jul 2025.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Danian Ji, M.D. study director
Huadong Hospital
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 alone and transparent cap-assisted colonoscopy combined with computer-aided detection in people with Colorectal Adenoma, run by Fudan 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 1 inclusion and 12 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: opening soon, as of the sponsor's last update on 31 Jul 2025. 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 Danian Ji, M.D. (+86-18019094606, arctg4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: 2 weeks after the procedure). 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 31 Jul 2025.