Laser Measurement for Polyps

Recruiting 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

138 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is laser measurement for polyps safe for humans?

The research articles primarily discuss the potential for retinal (eye) damage from laser exposure, indicating that lasers can be harmful to the eyes if not used properly. However, there is no specific safety data available for laser measurement for polyps in humans. ^{1 2 3 4 5}

How does the treatment AccuMeasure for polyps differ from other treatments?

AccuMeasure is unique because it uses laser technology to precisely measure polyps, which can improve the accuracy of treatment planning compared to traditional methods that rely on manual or less precise measurements. ^{6 7 8 9 10}

Eligibility Criteria

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 over 18 years old.

I am scheduled for a colonoscopy.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Retinal damage thresholds from single-pulse laser exposures in the visible spectrum. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Blue Laser Induced Retinal Injury in a Commercial Pilot at 1300 ft. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Retinal damage induced by red diode laser. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The illumination characteristics of operative microscopes. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

A sensitive and high dynamic range cw laser power meter. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Automated polyp measurement with CT colonography: preliminary observations in a phantom colon model. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

CT colonography: automated measurement of colonic polyps compared with manual techniques--human in vitro study. [2016]

8. England pubmed.ncbi.nlm.nih.gov

A prospective study of the accuracy and concordance between in-situ and postfixation measurements of colorectal polyp size and their potential impact upon surveillance. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Precise tumor size measurement under constant pressure by novel real-time micro-electro-mechanical-system hood for proper treatment (with videos). [2021]

10. United States pubmed.ncbi.nlm.nih.gov

CT colonography: effect of colonic distension on polyp measurement accuracy and agreement-in vitro study. [2016]