Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance
D
Douglas Rex, MD
Primary Investigator
Enrolling By Invitation
18 years or above
All
Phase
N/A
138 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE)gly focus on size of polyps as an important indicator of malignant transformation to(CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead tourveillance intervals in patients at risk for developing colorectal cancer, whichy increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess thew laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) foryps during colonoscopy.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Persons scheduled for a colonoscopy will be invited to participate in the study after a member of the research team screens the patient for inclusion and exclusion criteria using the clinic schedules/medical records. A member of the research team will approach subjects that are already scheduled for colonoscopies on the day of the procedure to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented.
Detailed description of study
What will happen during the study?
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: Timeded for measurement and learning curve, endoscopists advised surveillance intervals basedboth measurement methods, and safety.
All adult patients with screening or surveillance colonoscopies will beked for informed consent. Polyps smaller than 25mm found during colonoscopy are consideredgible 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,urement with AccuMeasure and biopsy forceps will be performed in a randomized order. Thedoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learninghat could influence subsequent measurements.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Colorectal Polyp
-
Age: 18 years or above
-
Gender: All
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 medicationuse;
- Inability to provide informed consent;
- Inadequate bowel preparation (Boston bowel preparation scale score [BBPS] <2 pergment);
- No polyps identified during colonoscopy or only small (<5mm) hyperplastic rectalyps;
- Intraprocedural complications, not caused by the study device.
Updated on
05 Apr 2025.
Study ID: GI-VTM-POLYP-SIZE, NL80961.091.22, 16685
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