Colorectal PolypNCT04754347
Computer Aided Detection of Polyps in Colonoscopy
A study testing Computer Aided Detection device in people with Colorectal Polyp, run by Iterative Scopes, Inc at 5 sites in United States.
Trial summary
The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Computer Aided Detection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,472 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Jan 2021to 31 Oct 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible for this study if they are:
- Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
- Undergoing a procedure by a participating endoscopist.
- Have given informed consent.
Who cannot join
- Participants will not be eligible for this study if they:
- Have a history of inflammatory bowel disease.
- Have a history of familial adenomatous polyposis.
- Are under the age of 40.
- Have had a colonoscopy within the previous three (3) years.
- Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
- Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator).
- Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Mount Auburn Hospital
Cambridge, Massachusetts, 02138
Concord Endoscopy Center
Concord, New Hampshire, 03301
MNGI Digestive Health
Plymouth, Minnesota, 55446
About this study
Official title: Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
- Conditions
- Colorectal Polyp
- Being tested
- Computer Aided Detection device
- Keywords
- Screening Colonoscopy, Artificial Intelligence, Computer Aided Detection, Adenoma Detection Rate, Adenomas per Colonoscopy, Surveillance Colonoscopy, Colorectal Cancer, Software as a Medical Device
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Aided Detection deviceDevice
The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine Colonoscopy |
| Experimental | Experimental | Routine Colonoscopy with the use of Skout Receives: Device: Computer Aided Detection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenomas per colonoscopy
The total number of adenomas detected divided by the total number of colonoscopies.
Measured: At the end of the procedure, 1 day
Positive predictive value
The total number of adenomas and serrated lesions detected divided by the total number of extractions.
Measured: At the end of the procedure, 1 day
Secondary outcomes (3)
Adenoma detection rate
The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.
Measured: At the end of the procedure, 1 day
Sessile serrated lesions detected
The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.
Measured: At the end of the procedure, 1 day
Colorectal cancer surveillance interval
The mean recommended timeframe for follow up colonoscopy.
Measured: At the end of the procedure, 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start22 Jan 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 Colorectal PolypStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iterative Scopes, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Aasma Shaukat, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754347
- Sponsor's protocol ID
- Pro00047634
- Status last verified
- Nov 2021
- First submitted
- 10 Feb 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT Registration Study Team. Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25.
PubMed 35643173
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
- ClinicalTrials.gov ID
- NCT04754347
- Acronym / sponsor ID
- Pro00047634
- Conditions
- Colorectal Polyp
- Keywords
- Screening Colonoscopy, Artificial Intelligence, Computer Aided Detection, Adenoma Detection Rate, Adenomas per Colonoscopy, Surveillance Colonoscopy, Colorectal Cancer, Software as a Medical Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,472 participants (actual)
- Lead sponsor
- Iterative Scopes, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Feb 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.
The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine Colonoscopy |
| Experimental | Experimental | Device: Computer Aided Detection deviceRoutine Colonoscopy with the use of Skout |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
- Undergoing a procedure by a participating endoscopist.
- Have given informed consent.
Key exclusion criteria (8 listed)
- Have a history of inflammatory bowel disease.
- Have a history of familial adenomatous polyposis.
- Are under the age of 40.
- Have had a colonoscopy within the previous three (3) years.
- Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
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 |
|---|---|---|
| Computer Aided Detection deviceThe Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor. | Device | Experimental |
Primary outcome
Adenomas per colonoscopy
Time frame: At the end of the procedure, 1 day
The total number of adenomas detected divided by the total number of colonoscopies.
Positive predictive value
Time frame: At the end of the procedure, 1 day
The total number of adenomas and serrated lesions detected divided by the total number of extractions.
3 secondary outcomes
Adenoma detection rate
Time frame: At the end of the procedure, 1 day
Sessile serrated lesions detected
Time frame: At the end of the procedure, 1 day
Colorectal cancer surveillance interval
Time frame: At the end of the procedure, 1 day
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 1 Dec 2021.
- Derived from this study: PubMed 35643173Shaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT Registration Study Team. Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25.
- Individual participant dataSharing planned: No
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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.
Aasma Shaukat, MD, MPH principal investigator
University of Minnesota
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Aided Detection device in people with Colorectal Polyp, run by Iterative Scopes, Inc at 5 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 4 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 1 Dec 2021. 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. 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?
Adenomas per colonoscopy (time frame: At the end of the procedure, 1 day). The study lists 2 primary outcomes in all. 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 NCT04754347, 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 1 Dec 2021.