Colonoscope PassageNCT06992856
The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
A study testing Conventional colonoscope passage, left colon water exchange colonoscope passage and cap-assisted left colon water exchange colonoscope passage in people with Colonoscope Passage, run by Fudan University at 1 site in China.
Trial summary
A prospective, single-center, single-blind, randomized controlled study to compare the proportion of straight passage through the sigmoid colon without loop formation between conventional colonoscope passage, left colon water exchange colonoscope passage, and cap-assisted left colon water exchange colonoscope passage… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscope Passage
- What is being tested?
- Conventional colonoscope passage, left colon water exchange colonoscope passage and cap-assisted left colon water exchange colonoscope passage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 531 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-80 years
- sedation colonoscopy
Who cannot join
- History of colorectal surgery
- Clinical suspicion of, or pathologically confirmed, colorectal cancer
- Presence of any "alarm" symptom or sign-hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination
- Pregnancy or lactation
- Known or suspected gastrointestinal obstruction
- Diagnosed inflammatory bowel disease
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- Use of antiplatelet or anticoagulant therapy (e.g., aspirin, warfarin) within 7 days before colonoscopy or any documented coagulation disorder
- Current enrolment in another clinical study or participation in any clinical trial within the previous 60 days
- Requirement for emergency colonoscopy
- Any other condition that, in the investigators' judgment, renders the patient unsuitable for inclusion in the study
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 affiliated to 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
A prospective, single-center, single-blind, randomized controlled study to compare the proportion of straight passage through the sigmoid colon without loop formation between conventional colonoscope passage, left colon water exchange colonoscope passage, and cap-assisted left colon water exchange colonoscope passage through the sigmoid colon
Read the detailed description
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients into 3 interventional groups based on R script (version 4.4.1), including (1) Group 1: Conventional colonoscope passage, (2) Group 2: left colon water exchange colonoscope passage, (3) Group 3: cap-assisted left colon water exchange colonoscope passage.
- Collecting variables which consist of primary and secodary outcomes.
- Conditions
- Colonoscope Passage
- Being tested
- Conventional colonoscope passage, left colon water exchange colonoscope passage, cap-assisted left colon water exchange colonoscope passage
- Keywords
- colonoscope passage, left colon water exchange, cap-assisted, without loop formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional colonoscope passageProcedure or surgery
Use conventional colonoscope passage through the sigmoid colon
left colon water exchange colonoscope passageProcedure or surgery
Use left colon water exchange colonoscope passage through the sigmoid colon
cap-assisted left colon water exchange colonoscope passageProcedure or surgery
Use cap-assisted left colon water exchange colonoscope passage through sigmoid colon
| Study group | Role | What they receive |
|---|---|---|
| conventional colonoscope passage | Active comparator | Use conventional colonoscope passage through the sigmoid colon Receives: Procedure: Conventional colonoscope passage |
| left colon water exchange colonoscope passage | Experimental | Use left colon water exchange colonoscope passage through the sigmoid colon Receives: Procedure: left colon water exchange colonoscope passage |
| Cap-assisted left colon water exchange colonoscope passage | Experimental | Use Cap-assisted left colon water exchange colonoscope passage through the sigmoid colon Receives: Procedure: cap-assisted left colon water exchange colonoscope passage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of straight passage through the sigmoid colon without loop formation
Measured: immediately after the procedure
Secondary outcomes (5)
Cecal intubation rate
Measured: immediately after the procedure
Cecal intubation time
Measured: immediately after the procedure
Time of insertion to cecum
Measured: immediately after the procedure
Colonoscope insertion failure rate
Measured: immediately after the procedure
Adenoma detection rate
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 posted28 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscope PassageStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 531 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
- NCT06992856
- Sponsor's protocol ID
- 2025K235
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 28 May 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
- ClinicalTrials.gov ID
- NCT06992856
- Acronym / sponsor ID
- 2025K235
- Conditions
- Colonoscope Passage
- Keywords
- colonoscope passage, left colon water exchange, cap-assisted, without loop formation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 531 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 May 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 proportion of straight passage through the sigmoid colon without loop formation between conventional colonoscope passage, left colon water exchange colonoscope passage, and cap-assisted left colon water exchange colonoscope passage through the sigmoid colon
Detailed description
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients into 3 interventional groups based on R script (version 4.4.1), including (1) Group 1: Conventional colonoscope passage, (2) Group 2: left colon water exchange colonoscope passage, (3) Group 3: cap-assisted left colon water exchange colonoscope passage.
- Collecting variables which consist of primary and secodary outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional colonoscope passage | Active comparator | Procedure: Conventional colonoscope passageUse conventional colonoscope passage through the sigmoid colon |
| left colon water exchange colonoscope passage | Experimental | Procedure: left colon water exchange colonoscope passageUse left colon water exchange colonoscope passage through the sigmoid colon |
| Cap-assisted left colon water exchange colonoscope passage | Experimental | Procedure: cap-assisted left colon water exchange colonoscope passageUse Cap-assisted left colon water exchange colonoscope passage through the sigmoid colon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-80 years
- sedation colonoscopy
Key exclusion criteria (10 listed)
- History of colorectal surgery
- Clinical suspicion of, or pathologically confirmed, colorectal cancer
- Presence of any "alarm" symptom or sign-hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination
- Pregnancy or lactation
- Known or suspected 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 |
|---|---|---|
| Conventional colonoscope passageUse conventional colonoscope passage through the sigmoid colon | Procedure or surgery | conventional colonoscope passage |
| left colon water exchange colonoscope passageUse left colon water exchange colonoscope passage through the sigmoid colon | Procedure or surgery | left colon water exchange colonoscope passage |
| cap-assisted left colon water exchange colonoscope passageUse cap-assisted left colon water exchange colonoscope passage through sigmoid colon | Procedure or surgery | Cap-assisted left colon water exchange colonoscope passage |
Primary outcome
The proportion of straight passage through the sigmoid colon without loop formation
Time frame: immediately after the procedure
5 secondary outcomes
Cecal intubation rate
Time frame: immediately after the procedure
Cecal intubation time
Time frame: immediately after the procedure
Time of insertion to cecum
Time frame: immediately after the procedure
Colonoscope insertion failure rate
Time frame: immediately after the procedure
Adenoma detection 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 28 May 2025.
- Individual participant dataSharing planned: Yes. All collected IPD
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 Conventional colonoscope passage, left colon water exchange colonoscope passage and cap-assisted left colon water exchange colonoscope passage in people with Colonoscope Passage, 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 2 inclusion and 10 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 28 May 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?
The proportion of straight passage through the sigmoid colon without loop formation (time frame: immediately 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 28 May 2025.