Colorectal PolypESTIMATENCT05846295
Online Education Module to Accurately Classify Polyp Size
A study testing ESTIMATE in people with Colorectal Polyp and Colonic Neoplasms, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Polyp, Colonic Neoplasms
- What is being tested?
- ESTIMATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 28 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GI trainees who have never received formal training in, nor had participated in a research study on, polyp sizing
- Informed consent
Who cannot join
- Those who do not complete the educational module during the allotted time
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Online Education Module (ESTIMATE: Estimating Polyp Size With Snare Tool to Improve Measurement Accuracy for Trainee Education) to Accurately Classify Polyp Size
Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Trainees from GI fellowship programs will be randomized to one of four groups: control (no video, no feedback), video-only, feedback-only, and video + feedback. Participants will classify polyps into one of three size categories:- diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm). Primary outcome is accuracy of polyp size classification [diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm)]. Secondary outcomes include accuracy of exact polyp size (in mm), cumulative accuracy (to plot learning curves), confidence level of polyp size classification, and directionality of inaccuracy (polyp size overestimation vs underestimation).
Read the detailed description
Study Design This is a prospective, multicenter educational randomized controlled trial. Trainees from five Accreditation Council for Graduate Medical Education (ACGME)-accredited GI fellowship training programs in the US will be invited to participate.
Study Materials (ESTIMATE Online Educational Module) The Estimating Polyp Size with Snare Tool to Improve Measurement Accuracy for Trainee Education (ESTIMATE) online educational module was developed by the study team over an 11-month development phase from September 2020 - August 2021. ESTIMATE is a user-friendly, interactive, web-based teaching module consisting of two main educational components: (1) video instruction and (2) real-time feedback during a polyp size assessment test. Video instruction is provided in a five-minute didactic clip that narrates the importance of accurate polyp size classification and demonstrates proper technique for positioning the snare to estimate polyp size. Examples of both correct and incorrect technique are provided. Several case examples, with opportunity for trainee interaction and response, are also included.
The polyp size assessment test includes 40 polyp sizing questions. Each question contains a still image of a polyp with an adjacent snare and asks participants to correctly identify the polyp's size into one of the following clinically relevant size categories: diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm), as well as the exact polyp size in mm. Participants are also asked to provide their confidence level (high or low) with each response. High confidence is defined as a sufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response. Low confidence is defined as an insufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response.
Real-time feedback on correct polyp size is provided immediately after a response is submitted in the form of a series of images with overlying graphics that demonstrate polyp size relative to the adjacent snare with a final image of the resected polyp affixed to a cork board and ruler. Investigators used measurement of the immediate post-resection, pre-formalin fixation polyp affixed to a cork board with an adjacent ruler to determine correct size. The feedback image deck will be provided in continuous fashion after each response as participants progress through the test.
Randomization In order to assess the impact of the key educational components of our module (video instruction and feedback), participants will be randomized in REDCap to one of four study groups: control, video-only, feedback-only, or video + feedback. The control group will complete the 40-item polyp size assessment test without receiving any video instruction or feedback. The video-only group will watch the video instructional clip and then completed the assessment, but will not receive any feedback after each question. The feedback-only group will receive feedback after each question, but will not watch the video. Lastly, the video + feedback group will receive both video instruction and feedback as they complete the assessment.
Data Collection and Reporting System All data will be collected and managed using Research Electronic Data capture (REDCap).
Statistical Analysis \& Sample Size Considerations Bivariable analyses will be performed to identify potential differences between groups. Binomial regressions will be conducted to detect differences between the control and intervention groups in accuracy of polyp size by size classification and exact size in mm. Generalized linear mixed models will be used to assess differences in confidence while accounting for multiple responses within each participant. Models will be evaluated using a type I error rate of 0.05. Analyses will be conducted using R version 4.1.1. In order to achieve 80% power to detect a 20% difference between the three intervention groups and the control group, we will need to enroll twelve trainees within each group (48 total).
- Conditions
- Colorectal Polyp, Colonic Neoplasms
- Being tested
- ESTIMATE
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTIMATEOther
An online educational module consisting of a video tutorial and feedback during a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No video tutorial, no feedback |
| Feedback | Active comparator | Feedback only Receives: Other: ESTIMATE |
| Video | Active comparator | Video tutorial only Receives: Other: ESTIMATE |
| Video + Feedback | Experimental | VIdeo tutorial and feedback Receives: Other: ESTIMATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (≥10 mm) category on 40 question polyp sizing test.
The gold standard polyp size for the polyp images on the polyp sizing test was determined by affixing the polyp to a cork board post-procedure and measuring it with an adjacent ruler. The actual polyp size was determined by meauring it against the adjacent ruler. Polyps 1-5 mm were categorized as diminutive, polyps 6-9 mm were categorized as small and polyps ≥10 mm were categorized as large.
Participants completed a 40 item polyp sizing test where participants designated the polyp as either dimunitive (1-5mm), small (6-9mm) or large (≥10mm). The primary outcome was the rate that each participant correctly designated polyp size categories based on the gold standard.
Measured: through study completion, estimated 1 year
Secondary outcomes (4)
Participant entered rate of accurate polyp size by millimeter on 40 question polyp sizing test.
Participant rate of accurate polyp size by millimeter (1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, etc) on 40 question polyp sizing test.
Measured: through study completion, estimated 1 year
Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test
Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test
Measured: through study completion, estimated 1 year
Participant report of categorical high versus low confidence on each response of the 40 item polyp sizing test
self-reported high vs low confidence of each polyp characterization. High confidence is defined as sufficient self-assessed confidence that participant can make a post-polypectomy surveillance interval recommendation based on their designation. This is categorical selection of "high" vs "low"
Measured: through study completion, estimated 1 year
Proportion of participant responses that underestimate actual polyp size category versus overestimate actual polyp size category on the 40-question polyp sizing test.
Proportion of responses that underestimate actual polyp size category (a small or large polyp categorized as diminutive or a large polyp categorized as small) versus overestimate actual polyp size category (a diminutive or small polyp characterized as large or a diminutive polyp characterized as small).
Measured: through study completion, estimated 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Nov 2021
- Primary completion30 Nov 2021
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is an educational intervention study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swati G Patel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846295
- Sponsor's protocol ID
- 20-1413
- Acronym
- ESTIMATE
- Status last verified
- Nov 2023
- First submitted
- 28 Mar 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2020 Mar;115(3):415-434. doi: 10.14309/ajg.0000000000000544. No abstract available.
PubMed 32039982Gopalswamy N, Shenoy VN, Choudhry U, Markert RJ, Peace N, Bhutani MS, Barde CJ. Is in vivo measurement of size of polyps during colonoscopy accurate? Gastrointest Endosc. 1997 Dec;46(6):497-502. doi: 10.1016/s0016-5107(97)70003-8.
PubMed 9434215Chaptini L, Chaaya A, Depalma F, Hunter K, Peikin S, Laine L. Variation in polyp size estimation among endoscopists and impact on surveillance intervals. Gastrointest Endosc. 2014 Oct;80(4):652-659. doi: 10.1016/j.gie.2014.01.053. Epub 2014 Mar 27.
PubMed 24679658Utsumi T, Horimatsu T, Seno H. Measurement bias of colorectal polyp size: Analysis of the Japan Endoscopy Database. Dig Endosc. 2019 Sep;31(5):589. doi: 10.1111/den.13447. Epub 2019 Jun 13. No abstract available.
PubMed 31120583Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2020 Mar;91(3):486-519. doi: 10.1016/j.gie.2020.01.029. Epub 2020 Feb 14. No abstract available.
PubMed 32067745Patel SG, May FP, Anderson JC, Burke CA, Dominitz JA, Gross SA, Jacobson BC, Shaukat A, Robertson DJ. Updates on Age to Start and Stop Colorectal Cancer Screening: Recommendations From the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2022 Jan 1;117(1):57-69. doi: 10.14309/ajg.0000000000001548.
PubMed 34962727Patel SG, Rastogi A, Austin G, Hall M, Siller BA, Berman K, Yen R, Bansal A, Ahnen DJ, Wani S. Gastroenterology trainees can easily learn histologic characterization of diminutive colorectal polyps with narrow band imaging. Clin Gastroenterol Hepatol. 2013 Aug;11(8):997-1003.e1. doi: 10.1016/j.cgh.2013.02.020. Epub 2013 Mar 1.
PubMed 23466714
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Education Module (ESTIMATE: Estimating Polyp Size With Snare Tool to Improve Measurement Accuracy for Trainee Education) to Accurately Classify Polyp Size
- ClinicalTrials.gov ID
- NCT05846295
- Acronym / sponsor ID
- ESTIMATE / 20-1413
- Conditions
- Colorectal Polyp, Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Northwestern University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 6 May 2023 (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.
Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Trainees from GI fellowship programs will be randomized to one of four groups: control (no video, no feedback), video-only, feedback-only, and video + feedback. Participants will classify polyps into one of three size categories:- diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm). Primary outcome is accuracy of polyp size classification [diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm)]. Secondary outcomes include accuracy of exact polyp size (in mm), cumulative accuracy (to plot learning curves), confidence level of polyp size classification, and directionality of inaccuracy (polyp size overestimation vs underestimation).
Detailed description
Study Design This is a prospective, multicenter educational randomized controlled trial. Trainees from five Accreditation Council for Graduate Medical Education (ACGME)-accredited GI fellowship training programs in the US will be invited to participate.
Study Materials (ESTIMATE Online Educational Module) The Estimating Polyp Size with Snare Tool to Improve Measurement Accuracy for Trainee Education (ESTIMATE) online educational module was developed by the study team over an 11-month development phase from September 2020 - August 2021. ESTIMATE is a user-friendly, interactive, web-based teaching module consisting of two main educational components: (1) video instruction and (2) real-time feedback during a polyp size assessment test. Video instruction is provided in a five-minute didactic clip that narrates the importance of accurate polyp size classification and demonstrates proper technique for positioning the snare to estimate polyp size. Examples of both correct and incorrect technique are provided. Several case examples, with opportunity for trainee interaction and response, are also included.
The polyp size assessment test includes 40 polyp sizing questions. Each question contains a still image of a polyp with an adjacent snare and asks participants to correctly identify the polyp's size into one of the following clinically relevant size categories: diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm), as well as the exact polyp size in mm. Participants are also asked to provide their confidence level (high or low) with each response. High confidence is defined as a sufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response. Low confidence is defined as an insufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response.
Real-time feedback on correct polyp size is provided immediately after a response is submitted in the form of a series of images with overlying graphics that demonstrate polyp size relative to the adjacent snare with a final image of the resected polyp affixed to a cork board and ruler. Investigators used measurement of the immediate post-resection, pre-formalin fixation polyp affixed to a cork board with an adjacent ruler to determine correct size. The feedback image deck will be provided in continuous fashion after each response as participants progress through the test.
Randomization In order to assess the impact of the key educational components of our module (video instruction and feedback), participants will be randomized in REDCap to one of four study groups: control, video-only, feedback-only, or video + feedback. The control group will complete the 40-item polyp size assessment test without receiving any video instruction or feedback. The video-only group will watch the video instructional clip and then completed the assessment, but will not receive any feedback after each question. The feedback-only group will receive feedback after each question, but will not watch the video. Lastly, the video + feedback group will receive both video instruction and feedback as they complete the assessment.
Data Collection and Reporting System All data will be collected and managed using Research Electronic Data capture (REDCap).
Statistical Analysis \& Sample Size Considerations Bivariable analyses will be performed to identify potential differences between groups. Binomial regressions will be conducted to detect differences between the control and intervention groups in accuracy of polyp size by size classification and exact size in mm. Generalized linear mixed models will be used to assess differences in confidence while accounting for multiple responses within each participant. Models will be evaluated using a type I error rate of 0.05. Analyses will be conducted using R version 4.1.1. In order to achieve 80% power to detect a 20% difference between the three intervention groups and the control group, we will need to enroll twelve trainees within each group (48 total).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is an educational intervention study.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No video tutorial, no feedback |
| Feedback | Active comparator | Other: ESTIMATEFeedback only |
| Video | Active comparator | Other: ESTIMATEVideo tutorial only |
| Video + Feedback | Experimental | Other: ESTIMATEVIdeo tutorial and feedback |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- GI trainees who have never received formal training in, nor had participated in a research study on, polyp sizing
- Informed consent
Key exclusion criteria (1 listed)
- Those who do not complete the educational module during the allotted time
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 |
|---|---|---|
| ESTIMATEAn online educational module consisting of a video tutorial and feedback during a questionnaire | Other | Feedback, Video, Video + Feedback |
Primary outcome
Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (≥10 mm) category on 40 question polyp sizing test.
Time frame: through study completion, estimated 1 year
The gold standard polyp size for the polyp images on the polyp sizing test was determined by affixing the polyp to a cork board post-procedure and measuring it with an adjacent ruler. The actual polyp size was determined by meauring it against the adjacent ruler. Polyps 1-5 mm were categorized as diminutive, polyps 6-9 mm were categorized as small and polyps ≥10 mm were categorized as large. Participants completed a 40 item polyp sizing test where participants designated the polyp as either dimunitive (1-5mm), small (6-9mm) or large (≥10mm). The primary outcome was the rate that each participant correctly designated polyp size categories based on the gold standard.
4 secondary outcomes
Participant entered rate of accurate polyp size by millimeter on 40 question polyp sizing test.
Time frame: through study completion, estimated 1 year
Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test
Time frame: through study completion, estimated 1 year
Participant report of categorical high versus low confidence on each response of the 40 item polyp sizing test
Time frame: through study completion, estimated 1 year
Proportion of participant responses that underestimate actual polyp size category versus overestimate actual polyp size category on the 40-question polyp sizing test.
Time frame: through study completion, estimated 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 32039982Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2020 Mar;115(3):415-434. doi: 10.14309/ajg.0000000000000544. No abstract available.
- Background: PubMed 9434215Gopalswamy N, Shenoy VN, Choudhry U, Markert RJ, Peace N, Bhutani MS, Barde CJ. Is in vivo measurement of size of polyps during colonoscopy accurate? Gastrointest Endosc. 1997 Dec;46(6):497-502. doi: 10.1016/s0016-5107(97)70003-8.
- Background: PubMed 24679658Chaptini L, Chaaya A, Depalma F, Hunter K, Peikin S, Laine L. Variation in polyp size estimation among endoscopists and impact on surveillance intervals. Gastrointest Endosc. 2014 Oct;80(4):652-659. doi: 10.1016/j.gie.2014.01.053. Epub 2014 Mar 27.
- Background: PubMed 31120583Utsumi T, Horimatsu T, Seno H. Measurement bias of colorectal polyp size: Analysis of the Japan Endoscopy Database. Dig Endosc. 2019 Sep;31(5):589. doi: 10.1111/den.13447. Epub 2019 Jun 13. No abstract available.
- Background: PubMed 32067745Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2020 Mar;91(3):486-519. doi: 10.1016/j.gie.2020.01.029. Epub 2020 Feb 14. No abstract available.
- Background: PubMed 34962727Patel SG, May FP, Anderson JC, Burke CA, Dominitz JA, Gross SA, Jacobson BC, Shaukat A, Robertson DJ. Updates on Age to Start and Stop Colorectal Cancer Screening: Recommendations From the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2022 Jan 1;117(1):57-69. doi: 10.14309/ajg.0000000000001548.
- Background: PubMed 23466714Patel SG, Rastogi A, Austin G, Hall M, Siller BA, Berman K, Yen R, Bansal A, Ahnen DJ, Wani S. Gastroenterology trainees can easily learn histologic characterization of diminutive colorectal polyps with narrow band imaging. Clin Gastroenterol Hepatol. 2013 Aug;11(8):997-1003.e1. doi: 10.1016/j.cgh.2013.02.020. Epub 2013 Mar 1.
- Individual participant dataSharing planned: No
Related trials for Colorectal Polyp
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Enrolling by invitation
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Colon Polyp, Adenoma
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.
Swati G Patel, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTIMATE in people with Colorectal Polyp and Colonic Neoplasms, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (≥10 mm) category on 40 question polyp sizing test. (time frame: through study completion, estimated 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846295, which also lists 7 linked publications.
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 30 Nov 2023.