Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications fo… (NCT05489380) | Clinical Trial Compass
CompletedNot Applicable
Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance
United States, Netherlands138 participantsStarted 2023-06-19
Plain-language summary
Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess the precision of a new laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) for polyps during colonoscopy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Adult patients (\>18 years)
* Scheduled for screening, surveillance, or diagnostic colonoscopy
* Polyps of all forms ≤ 25mm as assessed by the endoscopist
Exclusion Criteria:
* • Therapeutic colonoscopy;
* Inflammatory bowel disease (IBD);
* American Society of Anesthesiologists (ASA) score of \>3;
* Inadequately corrected anticoagulation disorder or anticoagulation medication use;
* Inability to provide informed consent;
* Inadequate bowel preparation (Boston bowel preparation scale score \[BBPS\] \<2 per segment);
* No polyps identified during colonoscopy or only small (\<5mm) hyperplastic rectal polyps;
* Intraprocedural complications, not caused by the study device.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.