Colorectal Cancer ScreeningLOOP-p1NCT07541924
The Impact of Image-Assisted Colonoscope on Patient Experience, Physician Workload, and Examination Quality
A study testing CT-Based Image-Assisted Colonoscope Insertion in people with Colorectal Cancer Screening and Colonic Polyps/Colonoscopy/Colorectal Neoplasms, run by DONG WU at 1 site in China.
Trial summary
Colonoscopy is the cornerstone for colorectal cancer screening, diagnosis, and post-treatment surveillance. Procedural quality is influenced by patient anatomy, particularly variations in colonic configuration such as sigmoid redundancy, looping, and low-lying transverse colon. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening, Colonic Polyps/Colonoscopy/Colorectal Neoplasms, Difficult Colonoscopy
- What is being tested?
- CT-Based Image-Assisted Colonoscope Insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2025to 28 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years, or expected natural survival >3 years
- Undergoing colonoscopy at Peking Union Medical College Hospital
- Presence of an abdominal/pelvic CT scan performed within ≤5 years and no - - - major abdominal surgery afterward
- Patient or legal guardian able to understand the study and provide written consent
Who cannot join
- No available CT or CT quality insufficient for anatomical evaluation
- Prior colonic surgery affecting anatomy (e.g., right hemicolectomy, transverse colectomy)
- Severe cardiopulmonary dysfunction or coagulopathy
- Pregnancy
- Refusal to participate or inability to complete questionnaires
- Patient or guardian unable to understand study requirements
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, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dong Wu, M.D.
About this study
Colonoscopy is the cornerstone for colorectal cancer screening, diagnosis, and post-treatment surveillance. Procedural quality is influenced by patient anatomy, particularly variations in colonic configuration such as sigmoid redundancy, looping, and low-lying transverse colon. These features prolong insertion time, increase patient discomfort, and elevate physician workload.
Evidence suggests that prior CT imaging can provide objective and individualized information on colonic anatomy-such as redundancy, angulation, and tortuosity-potentially predicting procedural difficulty. However, existing studies are mainly retrospective or descriptive, lacking prospective randomized evidence on clinical utility.
This single-blind, randomized controlled trial evaluates whether image-assisted colonoscope insertion, based on pre-existing abdominal/pelvic CT scans, can improve cecal intubation time, enhance patient experience, reduce operator workload, and improve overall examination quality compared with standard colonoscopy.
Read the detailed description
Colonoscopy performance varies widely among patients, with anatomical factors being major contributors to insertion difficulty. Prior CT colonography studies demonstrate high interindividual variability in colon length, flexures, and tortuosity, and up to 73% of patients experience looping during colonoscopy. Fluoroscopy-guided maneuvers have been shown to resolve looping in >95% of cases, highlighting the potential value of anatomical prediction.
This study investigates the feasibility and effectiveness of using information extracted from a patient's previous abdominal/pelvic CT scan (≤5 years) to guide insertion strategy during colonoscopy. Image-assisted guidance may help endoscopists anticipate looping patterns, identify redundant segments, and plan insertion maneuvers more effectively.
A total of 140 participants will be randomized 1:1 into an image-assisted group or standard group. The primary endpoint is cecal intubation time. Secondary endpoints include patient-reported pain (VAS), willingness for future colonoscopy, operator workload (NASA-TLX), looping events, total procedure time, and polyp detection rate. Consistency between CT-based predictions and actual procedural findings will also be assessed.
This trial will provide foundational evidence for individualized, anatomy-informed colonoscopy strategies and support future large-scale studies or AI-assisted implementation.
- Conditions
- Colorectal Cancer Screening, Colonic Polyps/Colonoscopy/Colorectal Neoplasms, Difficult Colonoscopy, Colonoscopy-Related Discomfort
- Being tested
- CT-Based Image-Assisted Colonoscope Insertion
- Keywords
- Colonoscopy, Cecal Intubation Time, Looping, Image-Assisted Colonoscopy, Personalized Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Based Image-Assisted Colonoscope InsertionOther
This intervention uses pre-existing abdominal or pelvic CT imaging (within 5 years, without major abdominal surgery) to assess individual colonic morphology prior to colonoscopy. Key CT-derived features include colonic redundancy, looping patterns, fixation points, and segmental angulation. Based on these findings, the endoscopist receives a structured, standardized briefing before colonoscope insertion, including predicted difficult segments and recommended insertion strategies. No additional imaging, radiation, or invasive procedures are used. The intervention aims to improve insertion efficiency, reduce patient discomfort, and lower operator workload compared with standard colonoscopy without image guidance.
| Study group | Role | What they receive |
|---|---|---|
| Image-Assisted Colonoscopy | Experimental | Participants undergo colonoscopy with pre-procedural review of their existing abdominal/pelvic CT scan (≤5 years).
Endoscopists complete a standardized imaging assessment form including predicted redundancy, looping type, tortuosity, and segmental laxity.
No additional imaging is performed. Receives: Other: CT-Based Image-Assisted Colonoscope Insertion |
| Standard Colonoscopy | No intervention | Participants undergo colonoscopy per routine clinical practice without CT-based anticipatory guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal Incubation Time (minutes)
Time from scope insertion to visualization of the cecum
Measured: Periprocedural (during colonoscopy procedure)
Secondary outcomes (5)
Pain Score (VAS 0-10)
Patient-reported pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Immediately after colonoscopy (periprocedural)
Physician Workload
NASA-TLX Score (0-100)
Measured: Immediately after colonoscopy
Willingness for Future Colonoscopy (5-point Likert scale)
Patient willingness to undergo repeat colonoscopy assessed using a 5-point Likert scale.
Measured: Immediately after colonoscopy
Polyp Detection Rate (PDR) (%)
Proportion of colonoscopies in which at least one polyp is detected.
Measured: During colonoscopy procedure
Number of Looping Attempts
Total number of looping events requiring corrective maneuvers during colonoscope insertion.
Measured: During colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start9 Dec 2025
- Primary completion30 Jan 2026
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DONG WU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DONG WU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541924
- Sponsor's protocol ID
- P20251209-1001
- Other IDs
- 2024YFA0918504
- Acronym
- LOOP-p1
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared. Only aggregated results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Image-Assisted Colonoscope on Patient Experience, Physician Workload, and Examination Quality
- ClinicalTrials.gov ID
- NCT07541924
- Acronym / sponsor ID
- LOOP-p1 / P20251209-1001
- Conditions
- Colorectal Cancer Screening, Colonic Polyps/Colonoscopy/Colorectal Neoplasms, Difficult Colonoscopy, Colonoscopy-Related Discomfort
- Keywords
- Colonoscopy, Cecal Intubation Time, Looping, Image-Assisted Colonoscopy, Personalized Colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DONG WUUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 21 Apr 2026 (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.
Colonoscopy is the cornerstone for colorectal cancer screening, diagnosis, and post-treatment surveillance. Procedural quality is influenced by patient anatomy, particularly variations in colonic configuration such as sigmoid redundancy, looping, and low-lying transverse colon. These features prolong insertion time, increase patient discomfort, and elevate physician workload.
Evidence suggests that prior CT imaging can provide objective and individualized information on colonic anatomy-such as redundancy, angulation, and tortuosity-potentially predicting procedural difficulty. However, existing studies are mainly retrospective or descriptive, lacking prospective randomized evidence on clinical utility.
This single-blind, randomized controlled trial evaluates whether image-assisted colonoscope insertion, based on pre-existing abdominal/pelvic CT scans, can improve cecal intubation time, enhance patient experience, reduce operator workload, and improve overall examination quality compared with standard colonoscopy.
Detailed description
Colonoscopy performance varies widely among patients, with anatomical factors being major contributors to insertion difficulty. Prior CT colonography studies demonstrate high interindividual variability in colon length, flexures, and tortuosity, and up to 73% of patients experience looping during colonoscopy. Fluoroscopy-guided maneuvers have been shown to resolve looping in >95% of cases, highlighting the potential value of anatomical prediction.
This study investigates the feasibility and effectiveness of using information extracted from a patient's previous abdominal/pelvic CT scan (≤5 years) to guide insertion strategy during colonoscopy. Image-assisted guidance may help endoscopists anticipate looping patterns, identify redundant segments, and plan insertion maneuvers more effectively.
A total of 140 participants will be randomized 1:1 into an image-assisted group or standard group. The primary endpoint is cecal intubation time. Secondary endpoints include patient-reported pain (VAS), willingness for future colonoscopy, operator workload (NASA-TLX), looping events, total procedure time, and polyp detection rate. Consistency between CT-based predictions and actual procedural findings will also be assessed.
This trial will provide foundational evidence for individualized, anatomy-informed colonoscopy strategies and support future large-scale studies or AI-assisted implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Image-Assisted Colonoscopy | Experimental | Other: CT-Based Image-Assisted Colonoscope InsertionParticipants undergo colonoscopy with pre-procedural review of their existing abdominal/pelvic CT scan (≤5 years). Endoscopists complete a standardized imaging assessment form including predicted redundancy, looping type, tortuosity, and segmental laxity. No additional imaging is performed. |
| Standard Colonoscopy | No intervention | –Participants undergo colonoscopy per routine clinical practice without CT-based anticipatory guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years, or expected natural survival >3 years
- Undergoing colonoscopy at Peking Union Medical College Hospital
- Presence of an abdominal/pelvic CT scan performed within ≤5 years and no - - - major abdominal surgery afterward
- Patient or legal guardian able to understand the study and provide written consent
Key exclusion criteria (6 listed)
- No available CT or CT quality insufficient for anatomical evaluation
- Prior colonic surgery affecting anatomy (e.g., right hemicolectomy, transverse colectomy)
- Severe cardiopulmonary dysfunction or coagulopathy
- Pregnancy
- Refusal to participate or inability to complete questionnaires
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 |
|---|---|---|
| CT-Based Image-Assisted Colonoscope InsertionThis intervention uses pre-existing abdominal or pelvic CT imaging (within 5 years, without major abdominal surgery) to assess individual colonic morphology prior to colonoscopy. Key CT-derived features include colonic redundancy, looping patterns, fixation points, and segmental angulation. Based on these findings, the endoscopist receives a structured, standardized briefing before colonoscope insertion, including predicted difficult segments and recommended insertion strategies. No additional imaging, radiation, or invasive procedures are used. The intervention aims to improve insertion efficiency, reduce patient discomfort, and lower operator workload compared with standard colonoscopy without image guidance. | Other | Image-Assisted Colonoscopy |
Primary outcome
Cecal Incubation Time (minutes)
Time frame: Periprocedural (during colonoscopy procedure)
Time from scope insertion to visualization of the cecum
5 secondary outcomes
Pain Score (VAS 0-10)
Time frame: Immediately after colonoscopy (periprocedural)
Physician Workload
Time frame: Immediately after colonoscopy
Willingness for Future Colonoscopy (5-point Likert scale)
Time frame: Immediately after colonoscopy
Polyp Detection Rate (PDR) (%)
Time frame: During colonoscopy procedure
Number of Looping Attempts
Time frame: During colonoscopy 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 21 Apr 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared. Only aggregated results will be published.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-Based Image-Assisted Colonoscope Insertion in people with Colorectal Cancer Screening and Colonic Polyps/Colonoscopy/Colorectal Neoplasms, run by DONG WU 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 4 inclusion and 6 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 21 Apr 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 Kun He, MD (15901623698, hk6290418@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cecal Incubation Time (minutes) (time frame: Periprocedural (during colonoscopy 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 21 Apr 2026.