Optical Diagnosis Versus Laser Measurement of Polyps' Siz... | NCT05489380

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

NCT05489380

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Mar 3, 2026Actual

Enrollment

138Actual

Phase

Not Applicable

Conditions

Colorectal Polyp

Interventions

AccuMeasure

Countries

United States
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2023Actual

Primary Completion Date

Aug 28, 2025Actual

Completion Date

Mar 1, 2026Actual

First Submitted Date

Aug 3, 2022

First Submission Date that Met QC Criteria

Aug 4, 2022

First Posted Date

Aug 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 3, 2026Actual

Name	Class
Tel-Aviv Sourasky Medical Center	OTHER_GOV
Erasmus Medical Center	OTHER
Bnai Zion Medical Center	OTHER_GOV
NYU Langone Health

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Accumeasure last	Other	Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement	Device: AccuMeasure
AccuMeasure first	Other	optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2)	Device: AccuMeasure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AccuMeasure	Device	intracolonoscopy measurement of polyps using a laser-based device	AccuMeasure first Accumeasure last

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohens' Kappa coefficient	interobserver agreement between AccuMeasure and biopsy forceps assisted measurement	at colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with adverse events up to 30 days post colonoscopy	Number of Participants with adverse events	30 days post colonoscopy
Absolute size differences	Size differences for optical/biopsy forceps/AM assessment as compared to pathology size measurement;

Other Outcomes

Measure	Description	Time Frame
Method of polyp removal	method of polyp removal, i.e., polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection	at colonscopy
BBPS	Boston bowel preparation scale score (BBPS), in which segmental scores of 0 are worst and scores of 3 are best (completely clean)

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Hospital		Indianapolis	Indiana	46202	United States
NYU Langone Health

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The dataset used during this study is available from the corresponding author upon reasonable request

Types

Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code

Time Frame

15y

Access Criteria

The dataset used during this study is available from the corresponding author upon reasonable request

URL

Not provided

Intervention Model Description

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).

Masking Info

Masking

Single

Masking Description

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.

Who Masked

Outcomes Assessor