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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size

NCT07005453

Colorectal Polyps

RECRUITING NA

Virtual Scale Function SCALE EYE: Variability and Systematic Differences

NCT05499546

Polyp of Colon

COMPLETED NA

A Prospective Study to Evaluate the Performance of a Real-time System in the Estimation of Colorectal Polyp Size

NCT06957015

Colonic Polyps CRC (Colorectal Cancer) Artificial Intelligence (AI)

NOT_YET_RECRUITING NA

Computer Assisted Optical Assessment of Small Colorectal Polyps

NCT02522702

Colonic Polyps

UNKNOWN

Endoscopic Size Assessment of Advanced Adenomatous Polyps

NCT02193646

Adenoma Detection Rate Improvement in Screening Colonoscopy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Polyp

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

As optical assessment of polyps has a high interobserver variability, the order of polyps' size measurement using biopsy forceps or AM will be randomized per patient. Therefore, this study consists of two arms: Optical polyp size assessment, followed by biopsy forceps and then AM measurement (1), and optical assessment, followed by AM measurement and then biopsy forceps assisted assessment (2) (Figure 1).

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

the endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements. Even so, all pathologist assessments will be done independent of the study allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Accumeasure last

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

Group Type OTHER

AccuMeasure

Intervention Type DEVICE

intracolonoscopy measurement of polyps using a laser-based device

AccuMeasure first

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

Group Type OTHER

AccuMeasure

Intervention Type DEVICE

intracolonoscopy measurement of polyps using a laser-based device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AccuMeasure

intracolonoscopy measurement of polyps using a laser-based device

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

laser-based polyp measurement

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes