Colorectal AdenomaNCT07261319
Evaluating the Clinical Value of Transparent Cap-Assisted Second Examination of the Sigmoid Colon for Improving Colorectal Adenoma Detection Rates
A study testing standard second examination of the sigmoid colon and transparent cap-assisted second examination of the sigmoid colon 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 evaluate the clinical value of transparent cap-assisted second examination of the sigmoid colon for improving colorectal adenoma detection rates 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?
- standard second examination of the sigmoid colon and transparent cap-assisted second examination of the sigmoid colon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 15 Dec 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 13Show 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
- Inadequate withdrawal time (defined as a withdrawal time <6 minutes during the first examination or <2 minutes during the second examination)
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
About this study
Official title: Evaluating the Clinical Value of Transparent Cap-Assisted Second Examination of the Sigmoid Colon for Improving Colorectal Adenoma Detection Rates：A Single-center, Randomized Controlled Study
A prospective, single-center, single-blind, randomized controlled study to evaluate the clinical value of transparent cap-assisted second examination of the sigmoid colon for improving colorectal adenoma detection rates
Read the detailed description
Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with the increasing Westernization of diet and lifestyle, the incidence and prevalence of CRC in China have risen rapidly, making CRC one of the most common gastrointestinal malignancies in the country. Its incidence and mortality now rank second and fifth, respectively, among all cancers. The disease burden of CRC in China has become substantial, and reducing its incidence and mortality is an urgent public health priority. Colonoscopy is the gold standard for CRC screening, and timely endoscopic management of precancerous lesions plays a critical role in reducing both CRC incidence and mortality.
Interval CRC refers to cancers diagnosed before the next recommended examination after a negative screening or surveillance colonoscopy. Adenoma detection rate (ADR) is an independent predictor of interval CRC risk; long-term follow-up data suggest that every 1% increase in ADR corresponds to a 5% reduction in the risk of interval CRC and a 3% reduction in mortality. However, emerging evidence indicates that interval CRC can still occur even among endoscopists with high ADRs, suggesting that some precancerous lesions may still be missed.
The main contributors to missed colorectal adenomas include: (1) operator-related factors such as fatigue, reduced attention, or limited lesion recognition; (2) image-related factors such as low-resolution visualization; and (3) inadequate mucosal exposure due to residual folds. In recent years, several studies have explored the use of "repeat intubation" to reduce missed adenomas. Multiple randomized controlled trials (RCTs) and systematic reviews have shown that a second examination can increase ADR, but most studies have focused on the right colon and often relied on chromoendoscopy or other image-enhancement modalities to improve lesion visibility. Evidence regarding second intubation specifically for the sigmoid colon remains limited, and even fewer studies have evaluated interventions based on transparent cap-assisted colonoscopy. Given that the sigmoid colon is a common site for missed polyps and adenomas, optimizing visualization in this segment may have a significant impact on overall ADR and CRC prevention.
In summary, there is still a lack of clinical evidence on whether transparent cap-assisted second intubation of the sigmoid colon can improve colorectal adenoma detection. A randomized controlled trial in the Chinese population is therefore needed to clarify its clinical value, with the potential to increase lesion detection and improve the overall quality of colonoscopy.
- Conditions
- Colorectal Adenoma
- Being tested
- standard second examination of the sigmoid colon, transparent cap-assisted second examination of the sigmoid colon
- Keywords
- transparent cap, adenoma detection rate, second examination, sigmoid colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard second examination of the sigmoid colonDevice
standard second examination of the sigmoid colon
transparent cap-assisted second examination of the sigmoid colonDevice
transparent cap-assisted second examination of the sigmoid colon
| Study group | Role | What they receive |
|---|---|---|
| Standard second examination of the sigmoid colon | Active comparator | Standard second examination of the sigmoid colon Receives: Device: standard second examination of the sigmoid colon |
| transparent cap-assisted second examination of the sigmoid colon | Experimental | transparent cap-assisted second examination of the sigmoid colon Receives: Device: transparent cap-assisted second examination of the sigmoid colon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate in the rectum and sigmoid colon
Measured: 2 weeks after the procedure
Secondary outcomes (12)
Increased adenoma detection rate in the rectum and sigmoid colon achieved by second examination
Measured: 2 weeks after the procedure
Adenoma miss rate in the rectum and sigmoid colon
Measured: 2 weeks after the procedure
Per-colonoscopy adenoma miss rate in the rectum and sigmoid colon
Measured: 2 weeks after the procedure
Sessile serrated lesion detection rate in rectum and sigmoid colon
Measured: 2 weeks after the procedure
Advanced adenoma detection rate in rectum and sigmoid colon
Measured: 2 weeks after the procedure
Polyp detection rate in rectum and sigmoid colon
Measured: 2 weeks after the procedure
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
Perforation rate
Measured: immediately 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 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
- 614 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, Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261319
- Sponsor's protocol ID
- 2025K351
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Value of Transparent Cap-Assisted Second Examination of the Sigmoid Colon for Improving Colorectal Adenoma Detection Rates：A Single-center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07261319
- Acronym / sponsor ID
- 2025K351
- Conditions
- Colorectal Adenoma
- Keywords
- transparent cap, adenoma detection rate, second examination, sigmoid colon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 3 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.
A prospective, single-center, single-blind, randomized controlled study to evaluate the clinical value of transparent cap-assisted second examination of the sigmoid colon for improving colorectal adenoma detection rates
Detailed description
Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with the increasing Westernization of diet and lifestyle, the incidence and prevalence of CRC in China have risen rapidly, making CRC one of the most common gastrointestinal malignancies in the country. Its incidence and mortality now rank second and fifth, respectively, among all cancers. The disease burden of CRC in China has become substantial, and reducing its incidence and mortality is an urgent public health priority. Colonoscopy is the gold standard for CRC screening, and timely endoscopic management of precancerous lesions plays a critical role in reducing both CRC incidence and mortality.
Interval CRC refers to cancers diagnosed before the next recommended examination after a negative screening or surveillance colonoscopy. Adenoma detection rate (ADR) is an independent predictor of interval CRC risk; long-term follow-up data suggest that every 1% increase in ADR corresponds to a 5% reduction in the risk of interval CRC and a 3% reduction in mortality. However, emerging evidence indicates that interval CRC can still occur even among endoscopists with high ADRs, suggesting that some precancerous lesions may still be missed.
The main contributors to missed colorectal adenomas include: (1) operator-related factors such as fatigue, reduced attention, or limited lesion recognition; (2) image-related factors such as low-resolution visualization; and (3) inadequate mucosal exposure due to residual folds. In recent years, several studies have explored the use of "repeat intubation" to reduce missed adenomas. Multiple randomized controlled trials (RCTs) and systematic reviews have shown that a second examination can increase ADR, but most studies have focused on the right colon and often relied on chromoendoscopy or other image-enhancement modalities to improve lesion visibility. Evidence regarding second intubation specifically for the sigmoid colon remains limited, and even fewer studies have evaluated interventions based on transparent cap-assisted colonoscopy. Given that the sigmoid colon is a common site for missed polyps and adenomas, optimizing visualization in this segment may have a significant impact on overall ADR and CRC prevention.
In summary, there is still a lack of clinical evidence on whether transparent cap-assisted second intubation of the sigmoid colon can improve colorectal adenoma detection. A randomized controlled trial in the Chinese population is therefore needed to clarify its clinical value, with the potential to increase lesion detection and improve the overall quality of colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard second examination of the sigmoid colon | Active comparator | Device: standard second examination of the sigmoid colonStandard second examination of the sigmoid colon |
| transparent cap-assisted second examination of the sigmoid colon | Experimental | Device: transparent cap-assisted second examination of the sigmoid colontransparent cap-assisted second examination of the sigmoid colon |
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 (13 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 |
|---|---|---|
| standard second examination of the sigmoid colonstandard second examination of the sigmoid colon | Device | Standard second examination of the sigmoid colon |
| transparent cap-assisted second examination of the sigmoid colontransparent cap-assisted second examination of the sigmoid colon | Device | transparent cap-assisted second examination of the sigmoid colon |
Primary outcome
Adenoma detection rate in the rectum and sigmoid colon
Time frame: 2 weeks after the procedure
12 secondary outcomes
Increased adenoma detection rate in the rectum and sigmoid colon achieved by second examination
Time frame: 2 weeks after the procedure
Adenoma miss rate in the rectum and sigmoid colon
Time frame: 2 weeks after the procedure
Per-colonoscopy adenoma miss rate in the rectum and sigmoid colon
Time frame: 2 weeks after the procedure
Sessile serrated lesion detection rate in rectum and sigmoid colon
Time frame: 2 weeks after the procedure
Advanced adenoma detection rate in rectum and sigmoid colon
Time frame: 2 weeks after the procedure
Polyp detection rate in rectum and sigmoid colon
Time frame: 2 weeks after the procedure
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
Perforation rate
Time frame: immediately 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
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 3 Dec 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 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 standard second examination of the sigmoid colon and transparent cap-assisted second examination of the sigmoid colon 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 13 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 3 Dec 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 in the rectum and sigmoid colon (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 3 Dec 2025.