Polyp ColorectalNCT04979962
AI Colorectal Polyp Detection
A study testing EW10-EC02 (Endoscopy Support Program) in people with Polyp Colorectal and Adenoma Colon, run by Fujifilm Medical Systems USA, Inc. at 10 sites in United States.
Trial summary
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyp Colorectal, Adenoma Colon
- What is being tested?
- EW10-EC02 (Endoscopy Support Program)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,162 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 Nov 2021to 21 Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
- Patients aged 45 or older
- Patients who can provide an informed consent
Who cannot join
- Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
- Patients who are pregnant or are planning pregnancy during study period
- Patients who are not able to or refuse to give informed consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
GI Associates
Flowood, Mississippi, 39232
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Largo Medical Center (HCA)
Largo, Florida, 33770
Keck Medicine University of Southern California
Los Angeles, California, 90033
New York University/Manhattan Endoscopy
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Medical Center
Seattle, Washington, 98104
About this study
Official title: Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.
- Conditions
- Polyp Colorectal, Adenoma Colon
- Being tested
- EW10-EC02 (Endoscopy Support Program)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EW10-EC02 (Endoscopy Support Program)Device
EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| CAC Group | Experimental | Inspection with computer assisted colonoscopy. Receives: Device: EW10-EC02 (Endoscopy Support Program) |
| CC Group | No intervention | Inspection with conventional colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma per colonoscopy (APC)
Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies
Measured: 1 day/procedure
Secondary outcomes (2)
Positive predictive value (PPV)
Total number of histologically confirmed adenomas and carcinomas detected during the colonoscopy, divided by the total number of excisions in the colonoscopy
Measured: 1 day/procedure
Adenoma detection rate (ADR)
proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy
Measured: 1 day/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start24 Nov 2021
- Primary completion30 Sep 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyp ColorectalStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prateek Sharma, MD, Principal investigator, Kansas City VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979962
- Sponsor's protocol ID
- P-21-006
- Status last verified
- Sep 2023
- First submitted
- 19 Jul 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Desai M, Ausk K, Brannan D, Chhabra R, Chan W, Chiorean M, Gross SA, Girotra M, Haber G, Hogan RB, Jacob B, Jonnalagadda S, Iles-Shih L, Kumar N, Law J, Lee L, Lin O, Mizrahi M, Pacheco P, Parasa S, Phan J, Reeves V, Sethi A, Snell D, Underwood J, Venu N, Visrodia K, Wong A, Winn J, Wright CH, Sharma P. Use of a Novel Artificial Intelligence System Leads to the Detection of Significantly Higher Number of Adenomas During Screening and Surveillance Colonoscopy: Results From a Large, Prospective, US Multicenter, Randomized Clinical Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1383-1391. doi: 10.14309/ajg.0000000000002664. Epub 2024 Jan 18.
PubMed 38235741
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy
- ClinicalTrials.gov ID
- NCT04979962
- Acronym / sponsor ID
- P-21-006
- Conditions
- Polyp Colorectal, Adenoma Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 28 Jul 2021 (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 study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAC Group | Experimental | Device: EW10-EC02 (Endoscopy Support Program)Inspection with computer assisted colonoscopy. |
| CC Group | No intervention | –Inspection with conventional colonoscopy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
- Patients aged 45 or older
- Patients who can provide an informed consent
Key exclusion criteria (3 listed)
- Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
- Patients who are pregnant or are planning pregnancy during study period
- Patients who are not able to or refuse to give informed consent
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 |
|---|---|---|
| EW10-EC02 (Endoscopy Support Program)EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis. | Device | CAC Group |
Primary outcome
Adenoma per colonoscopy (APC)
Time frame: 1 day/procedure
Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies
2 secondary outcomes
Positive predictive value (PPV)
Time frame: 1 day/procedure
Adenoma detection rate (ADR)
Time frame: 1 day/procedure
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 18 Sep 2023.
- Derived from this study: PubMed 38235741Desai M, Ausk K, Brannan D, Chhabra R, Chan W, Chiorean M, Gross SA, Girotra M, Haber G, Hogan RB, Jacob B, Jonnalagadda S, Iles-Shih L, Kumar N, Law J, Lee L, Lin O, Mizrahi M, Pacheco P, Parasa S, Phan J, Reeves V, Sethi A, Snell D, Underwood J, Venu N, Visrodia K, Wong A, Winn J, Wright CH, Sharma P. Use of a Novel Artificial Intelligence System Leads to the Detection of Significantly Higher Number of Adenomas During Screening and Surveillance Colonoscopy: Results From a Large, Prospective, US Multicenter, Randomized Clinical Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1383-1391. doi: 10.14309/ajg.0000000000002664. Epub 2024 Jan 18.
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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.
Prateek Sharma, MD principal investigator
Kansas City VA Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EW10-EC02 (Endoscopy Support Program) in people with Polyp Colorectal and Adenoma Colon, run by Fujifilm Medical Systems USA, Inc. at 10 sites 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 3 inclusion and 3 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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?
Adenoma per colonoscopy (APC) (time frame: 1 day/procedure). 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 NCT04979962, which also lists 1 linked publication.
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 18 Sep 2023.