Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance

Objective: The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to assess: Time needed for measurement and learning curve, endoscopists advised surveillance intervals based on both measurement methods, and safety.

Study design: Multicenter, randomized, parallel group, endoscopist blinded study, including the measurement of 138 polyps during standard colonoscopy. With a polyp detection rate of approximately 40%1, this results in up to 345 patients/colonoscopies to be included. Enrollment will conclude once 138 polyps are included in the study.

Study population: All adult patients with screening or surveillance colonoscopies will be asked for informed consent. Polyps smaller than 25mm found during colonoscopy are considered eligible for inclusion. Up to 3 polyps per patient can be included in this study.

Intervention: Optical assessment will be performed upon identification of the polyp. Then, measurement with AccuMeasure and biopsy forceps will be performed in a randomized order. The endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements.

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.