Screening ColonoscopyNCT06568523
Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
A study testing MAGENTIQ-COLO. in people with Screening Colonoscopy and Surveillance Colonoscopy, run by Magentiq Eye LTD at 5 sites in 3 countries.
Trial summary
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopy, Surveillance Colonoscopy
- What is being tested?
- MAGENTIQ-COLO.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 Sep 2024to 31 Aug 2025
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.
Who cannot join
- In situ polyps with known histology detected in a previous colonoscopy.
- No colorectal polyps detected during colonoscopy.
- Known or suspected inflammatory bowel disease.
- Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).
- Non-hereditary polyposis syndromes (e.g. Lynch syndrome).
- History of chemotherapy or radiation therapy for colorectal lesions.
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- Pregnancy.
- Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.).
- Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants, comorbidities) or patient refusal, as assessed by the endoscopist.
- Inability to provide informed consent.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21202
Erlanger Health System
Chattanooga, Tennessee, 37403
Israel2 sites
Assuta
Haifa, Select State
Hadassah Medical Organization
Jerusalem, 91120
About this study
Official title: A Multicenter Study to Evaluate the Diagnostic Performance of Computer-aided Polyp Size Classification of the MAGENTIQ-COLO During Real-time Colonoscopy
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
Read the detailed description
Colonoscopy is the gold standard for the detection and removal of premalignant colorectal polyps. Recommended post-polypectomy surveillance intervals are primarily based on pathological diagnosis and polyp size. However, accurate estimation of polyp size remains challenging, potentially influencing post-polypectomy surveillance intervals. Inaccuracies in size estimation may lead to either unnecessary or prematurely scheduled surveillance colonoscopies when overestimating size or lead to an increased risk of post-colonoscopy colorectal cancer or advanced neoplasia when underestimating size. Furthermore, diminutive (1-5mm) polyps pose challenges due to their high incidence and frequent pathological assessment. Proposed strategies to reduce this burden, such as the European Society of Gastrointestinal Endoscopy (ESGE) 'resect-and-discard' strategy, are infrequently used as non-expert endoscopists often do not meet diagnostic thresholds when using standard visual inspection. The MAGENTIQ-COLO computer-aided diagnosis (CADx) system by Magentiq Eye LTD, Haifa, Israel, addresses these challenges by providing real-time polyp size estimation and polyp characterization. Additionally, this study evaluates the diagnostic accuracy of the MAGENTIQ-COLO CADx system in an average-risk screening and surveillance colonoscopy population.
The primary objective of the study is to assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to classify polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the size classification using open biopsy forceps, or polypectomy snares, of known diameter.
This will be measured by comparing the sensitivity and specificity between the two size classifications. Secondary objective include:
- To assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to diagnose diminutive (rectosigmoid) colorectal polyps as neoplastic (adenoma or sessile serrated lesion (SSL)) with high-confidence compared to the pathology diagnosis. This will be measured by the sensitivity and specificity between the two diagnoses;
- To assess the diagnostic performance of the CADx system in measuring the size in millimeters and the size classification of colorectal polyps compared to the size measurement using open biopsy forceps, or polypectomy snare, of known diameter; this correlation will also be conducted for classifying polyps into diminutive (≤5mm), small (6-9mm), and advanced (≥10mm) size categories.
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter.
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO. Study subjects who are already referred for screening or surveillance colonoscopy, will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO. Diagnostic performance of polyp size classification and optical diagnosis with and without MAGENTIQ-COLO is evaluated with reference to open biopsy forceps, or polypectomy snare of known diameter size classification, and pathology-based diagnosis, respectively. There is no formal study subject follow-up. Study procedures will be performed intraprocedural during the colonoscopy. Final pathological diagnosis will be recorded from the electronic health record.
The unit of analysis is the colorectal polyp rather than a study subject. The study is planned to include 396 colorectal polyps. Based on an expected detection rate of approximately 1.20 polyps per colonoscopy in the study population, we assume that enrollment of 330 subjects will be sufficient to meet the study objectives.
- Conditions
- Screening Colonoscopy, Surveillance Colonoscopy
- Being tested
- MAGENTIQ-COLO.
- Keywords
- Colorectal Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Screening Colonoscopy, Surveillance Colonoscopy, Automatic Polyp Detection
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGENTIQ-COLO.Diagnostic test
Also called Model: AI-DETECT-GI / AI-DETECT-GI-CU
This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.
| Study group | Role | What they receive |
|---|---|---|
| Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. | Other | Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO. Receives: Diagnostic Test: MAGENTIQ-COLO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard.
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter.
The diagnostic performance of the CADx-assisted optical diagnosis to correctly classify colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity and specificity of the CADx-assisted optical diagnosis compared to an expected minimum of 70% sensitivity and 70% specificity.
Measured: During the Colonoscopy Procedure
Secondary outcomes (2)
CADx size measurement vs. open biopsy forceps
The diagnostic performance of the optical diagnosis of the CADx system for correctly classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity, specificity, and accuracy of the CADx-assisted optical diagnosis.
In addition, the correlation between the size measurement in millimeters by the CADx system and by using open biopsy forceps or polypectomy snare of known diameter will be calculated. This correlation will also be conducted for classifying polyps into diminutive (≤5mm), small (6-9mm), and advanced (≥10mm) size categories.
Measured: During the Colonoscopy Procedure
ESGE 'resect-and-discard' & 'leave-in-situ'
The diagnostic performance of high-confidence CADx-assisted optical diagnosis to correctly identify diminutive colorectal polyps as neoplastic (adenoma or SSL). This will be measured by the sensitivity and specificity of the high-confidence CADx-assisted optical diagnosis compared to the ESGE 'resect-and-discard' strategy; an expected minimum of 80% sensitivity and 80% specificity. Additionally, for diminutive polyps located in the rectosigmoid, the diagnostic performance will be compared to the ESGE 'leave-in-situ' strategy, with an expected minimum sensitivity of 90% and specificity of 80% for neoplastic diagnosis
Measured: During the Colonoscopy Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening ColonoscopyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magentiq Eye LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Siersema, MD, Ph.D., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568523
- Sponsor's protocol ID
- CL-0045
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Diagnostic Performance of Computer-aided Polyp Size Classification of the MAGENTIQ-COLO During Real-time Colonoscopy
- ClinicalTrials.gov ID
- NCT06568523
- Acronym / sponsor ID
- CL-0045
- Conditions
- Screening Colonoscopy, Surveillance Colonoscopy
- Keywords
- Colorectal Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Screening Colonoscopy, Surveillance Colonoscopy, Automatic Polyp Detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Magentiq Eye LTDIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 23 Aug 2024 (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.
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
Detailed description
Colonoscopy is the gold standard for the detection and removal of premalignant colorectal polyps. Recommended post-polypectomy surveillance intervals are primarily based on pathological diagnosis and polyp size. However, accurate estimation of polyp size remains challenging, potentially influencing post-polypectomy surveillance intervals. Inaccuracies in size estimation may lead to either unnecessary or prematurely scheduled surveillance colonoscopies when overestimating size or lead to an increased risk of post-colonoscopy colorectal cancer or advanced neoplasia when underestimating size. Furthermore, diminutive (1-5mm) polyps pose challenges due to their high incidence and frequent pathological assessment. Proposed strategies to reduce this burden, such as the European Society of Gastrointestinal Endoscopy (ESGE) 'resect-and-discard' strategy, are infrequently used as non-expert endoscopists often do not meet diagnostic thresholds when using standard visual inspection. The MAGENTIQ-COLO computer-aided diagnosis (CADx) system by Magentiq Eye LTD, Haifa, Israel, addresses these challenges by providing real-time polyp size estimation and polyp characterization. Additionally, this study evaluates the diagnostic accuracy of the MAGENTIQ-COLO CADx system in an average-risk screening and surveillance colonoscopy population.
The primary objective of the study is to assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to classify polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the size classification using open biopsy forceps, or polypectomy snares, of known diameter.
This will be measured by comparing the sensitivity and specificity between the two size classifications. Secondary objective include:
- To assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to diagnose diminutive (rectosigmoid) colorectal polyps as neoplastic (adenoma or sessile serrated lesion (SSL)) with high-confidence compared to the pathology diagnosis. This will be measured by the sensitivity and specificity between the two diagnoses;
- To assess the diagnostic performance of the CADx system in measuring the size in millimeters and the size classification of colorectal polyps compared to the size measurement using open biopsy forceps, or polypectomy snare, of known diameter; this correlation will also be conducted for classifying polyps into diminutive (≤5mm), small (6-9mm), and advanced (≥10mm) size categories.
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter.
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO. Study subjects who are already referred for screening or surveillance colonoscopy, will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO. Diagnostic performance of polyp size classification and optical diagnosis with and without MAGENTIQ-COLO is evaluated with reference to open biopsy forceps, or polypectomy snare of known diameter size classification, and pathology-based diagnosis, respectively. There is no formal study subject follow-up. Study procedures will be performed intraprocedural during the colonoscopy. Final pathological diagnosis will be recorded from the electronic health record.
The unit of analysis is the colorectal polyp rather than a study subject. The study is planned to include 396 colorectal polyps. Based on an expected detection rate of approximately 1.20 polyps per colonoscopy in the study population, we assume that enrollment of 330 subjects will be sufficient to meet the study objectives.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. | Other | Diagnostic Test: MAGENTIQ-COLO.Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.
Key exclusion criteria (10 listed)
- In situ polyps with known histology detected in a previous colonoscopy.
- No colorectal polyps detected during colonoscopy.
- Known or suspected inflammatory bowel disease.
- Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).
- Non-hereditary polyposis syndromes (e.g. Lynch syndrome).
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 |
|---|---|---|
| MAGENTIQ-COLO.Also: Model: AI-DETECT-GI / AI-DETECT-GI-CUThis is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible. | Diagnostic test | Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. |
Primary outcome
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard.
Time frame: During the Colonoscopy Procedure
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter. The diagnostic performance of the CADx-assisted optical diagnosis to correctly classify colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity and specificity of the CADx-assisted optical diagnosis compared to an expected minimum of 70% sensitivity and 70% specificity.
2 secondary outcomes
CADx size measurement vs. open biopsy forceps
Time frame: During the Colonoscopy Procedure
ESGE 'resect-and-discard' & 'leave-in-situ'
Time frame: During the Colonoscopy Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Peter Siersema, MD, Ph.D. principal investigator
Erasmus Medical Center
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGENTIQ-COLO. in people with Screening Colonoscopy and Surveillance Colonoscopy, run by Magentiq Eye LTD at 5 sites in 3 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Israel, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dror Zur, Ph.D (+972 547 555922, dror@magentiq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard. (time frame: During the Colonoscopy Procedure). 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 23 Aug 2024.