Laser Measurement for Polyps

Enrolling by invitation at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radboud University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Inflammatory bowel disease, ASA >3, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser-based tool called AccuMeasure to determine its accuracy in measuring polyps (growths) in the colon during a colonoscopy. Accurate polyp size measurements are crucial, as size helps doctors decide how often to check a patient for colorectal cancer. The trial compares this laser tool with other common methods of measuring polyps. Suitable participants are adults scheduled for a colonoscopy with polyps 25mm or smaller. As an unphased trial, this study allows participants to contribute to innovative research that could improve future colonoscopy procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation medication, you may not be eligible to participate.

What prior data suggests that this laser-based measurement system is safe for polyp assessment?

Research has shown that the AccuMeasure system is safe for measuring polyp sizes during colonoscopy. In past studies, no negative side effects occurred when using AccuMeasure to find polyps, meaning participants experienced no device-related problems. The tool aims to improve the accuracy of polyp size measurement, aiding in cancer risk assessment. This safety record may reassure potential trial participants about using AccuMeasure in the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Laser Measurement for Polyps trial because it explores new ways to assess polyp size using the AccuMeasure technique. Unlike traditional methods that rely heavily on biopsy forceps for size assessment, AccuMeasure offers an optical measurement approach. This could lead to more accurate and less invasive evaluations, potentially improving diagnosis and treatment planning for patients with polyps. By refining how polyps are measured, this method may enhance the precision of clinical decisions, which is a promising advancement in the field.

What evidence suggests that this laser-based measurement system is effective for assessing polyp size?

This trial will compare two methods of using the AccuMeasure laser system to measure polyp size. Studies have shown that the AccuMeasure laser system provides more accuracy than visual assessment alone. Specifically, one study found that AccuMeasure achieved 84% accuracy in measuring polyp size, compared to 68.4% accuracy with visual assessment. This precision is crucial for determining how often someone should be screened for colorectal cancer. Accurate measurement aids doctors in making informed decisions about follow-up care and may reduce the risk of missing cancers after a colonoscopy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are scheduled for a screening, surveillance, or diagnostic colonoscopy and have polyps that appear to be 25mm or smaller. It's not specified who can't join the trial.

Inclusion Criteria

I am scheduled for a colonoscopy.

I am over 18 years old.

Polyps of all forms ≤ 25mm as assessed by the endoscopist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Colonoscopy and Measurement

Participants undergo colonoscopy where polyps are assessed using optical diagnosis, AccuMeasure, and biopsy forceps

At colonoscopy

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and outcomes post colonoscopy

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• AccuMeasure

Trial Overview The study is testing AccuMeasure, a new laser-based tool designed to measure polyps during colonoscopy more accurately than current methods. This could help determine the correct follow-up schedule and reduce colorectal cancer risk.

How Is the Trial Designed?

Group I: Accumeasure last Experimental Treatment 1 Intervention

Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement

Group II: AccuMeasure first Experimental Treatment 1 Intervention

optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2)

Who Is Running the Clinical Trial?

Radboud University Medical Center

Lead Sponsor

Trials

1,203

Recruited

1,157,000+

Erasmus Medical Center

Collaborator

Trials

742

Recruited

2,156,000+

Universitätsklinikum Hamburg-Eppendorf

Collaborator

Trials

497

Recruited

2,984,000+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Bnai Zion Medical Center

Collaborator

Trials

114

Recruited

23,100+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Tel-Aviv Sourasky Medical Center

Collaborator

Trials

584

Recruited

331,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40019167/

Accuracy of Visual Estimation for Measuring Colonic Polyp ... Visual estimation is an inaccurate and imprecise way to measure colorectal polyps. Further research is needed to determine the impact on clinical outcomes ...

2. gi.org gi.org/journals-publications/ebgi/yen_oct2024/

A Laser Ruler to Hit the Mark on Polyp Size Overall, relative accuracy in size measurement was 84.0% with VSE compared to 68.4% with endoscopists' visual assessment alone (P < 0.001).

3. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/12307/optical-diagnosis-versus-laser/

Optical Diagnosis Versus Laser Measurement of Polyps' Size Objective: The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080523/

Use of artificial intelligence to measure colorectal polyp size ... Our study shows that colorectal polyp size measurement by AI model is practical and clinically useful, exhibiting low error rates and high precision.

5. researchgate.net researchgate.net/publication/389439855_Accuracy_of_Visual_Estimation_for_Measuring_Colonic_Polyp_Size_A_Systematic_Review_and_Meta-Analysis

Accuracy of Visual Estimation for Measuring Colonic Polyp ... This study aims to clarify the accuracy of visual estimation as a measurement tool, and the benefits of artificial intelligence. Methods MEDLINE ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210032.pdf

DEN210032 Summary - accessdata.fda.gov Adverse Events. There were no adverse events associated with using the AccuMcasure"™ System during the~ procedures where polyps were detected.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11774581/

Polyp size measurement during colonoscopy using a ... Background Accurate polyp size measurement is important for polyp risk stratification and decision-making regarding polypectomy and surveillance.

8. ctv.veeva.com ctv.veeva.com/study/optical-diagnosis-versus-laser-measurement-of-polyps-size-during-colonoscopy-and-implications-for-s

Optical Diagnosis Versus Laser Measurement of Polyps' Size ... Objective: The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06073405

Colonic Polyp Size Measurement With Artificial Intelligence Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28796738/

Measurement Bias of Polyp Size at Colonoscopy Colonoscopists may be inaccurate in the measurement of polyp size and appear biased towards and against certain size measurements.