Colorectal PolypNCT05489380
Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance
A study testing AccuMeasure in people with Colorectal Polyp, run by Radboud University Medical Center at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- AccuMeasure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Jun 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Adult patients (>18 years)
- Scheduled for screening, surveillance, or diagnostic colonoscopy
- Polyps of all forms ≤ 25mm as assessed by the endoscopist
Who cannot join
- • 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Indiana University Hospital
Indianapolis, Indiana, 46202
NYU Langone Health
New York, New York, 330306
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Official title: Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance (Polyp Size Study)
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.
Read the 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.
- Conditions
- Colorectal Polyp
- Being tested
- AccuMeasure
- Keywords
- screening, colonoscopy, surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuMeasureDevice
Also called laser-based polyp measurement
intracolonoscopy measurement of polyps using a laser-based device
| Study group | Role | What they receive |
|---|---|---|
| Accumeasure last | Other | Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement Receives: Device: AccuMeasure |
| AccuMeasure first | Other | optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2) Receives: Device: AccuMeasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohens' Kappa coefficient
interobserver agreement between AccuMeasure and biopsy forceps assisted measurement
Measured: at colonoscopy
Secondary outcomes (4)
Number of Participants with adverse events up to 30 days post colonoscopy
Number of Participants with adverse events
Measured: 30 days post colonoscopy
Absolute size differences
Size differences for optical/biopsy forceps/AM assessment as compared to pathology size measurement;
Measured: at colonoscopy
Time for measurement
Time for measurement with AccuMeasure related to number of measurements performed
Measured: at colonoscopy
Endoscopist advised surveillance interval
Endoscopist advised surveillance interval based on optical assessment during colonoscopy, on measurement with an open biopsy forceps, and on measurement with AccuMeasure
Measured: At colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start19 Jun 2023
- Primary completion28 Aug 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center, Erasmus Medical Center, Bnai Zion Medical Center, NYU Langone Health, Indiana University Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489380
- Sponsor's protocol ID
- NL80961.091.22
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The dataset used during this study is available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance (Polyp Size Study)
- ClinicalTrials.gov ID
- NCT05489380
- Acronym / sponsor ID
- NL80961.091.22
- Conditions
- Colorectal Polyp
- Keywords
- screening, colonoscopy, surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center, Erasmus Medical Center, Bnai Zion Medical Center, NYU Langone Health, Indiana University Health
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Accumeasure last | Other | Device: AccuMeasureOptical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement |
| AccuMeasure first | Other | Device: AccuMeasureoptical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Adult patients (>18 years)
Key exclusion criteria (8 listed)
- • Therapeutic colonoscopy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccuMeasureAlso: laser-based polyp measurementintracolonoscopy measurement of polyps using a laser-based device | Device | AccuMeasure first, Accumeasure last |
Primary outcome
Cohens' Kappa coefficient
Time frame: at colonoscopy
interobserver agreement between AccuMeasure and biopsy forceps assisted measurement
4 secondary outcomes
Number of Participants with adverse events up to 30 days post colonoscopy
Time frame: 30 days post colonoscopy
Absolute size differences
Time frame: at colonoscopy
Time for measurement
Time frame: at colonoscopy
Endoscopist advised surveillance interval
Time frame: At colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. The dataset used during this study is available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuMeasure in people with Colorectal Polyp, run by Radboud University Medical Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohens' Kappa coefficient (time frame: at colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.