Colo-rectal CancerNCT04195646
Computer Aided Detection of Polyps During Colonoscopy Procedures
A study testing EndoVigilant CAD Software in people with Colo-rectal Cancer and Polyp of Colon, run by EndoVigilant Inc at 2 sites in United States.
Trial summary
The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyps
- What is being tested?
- EndoVigilant CAD Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2019to 28 Feb 2020
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient presenting for routine colonoscopy for screening and/or surveillance purposes
- Ability to provide written, informed consent and understand the responsibilities of study participation
Who cannot join
- Patients with diminished cognitive capacity
- Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis
- Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greenbelt Endoscopy Center
Greenbelt, Maryland, 20706
VA Palo Alto Healthcare
Palo Alto, California, 94304
About this study
The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.
Read the detailed description
The details of the proposed study are as follows:
- Colonoscopy will be performed in the same standard of care manner as if no study was taking place. The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor. The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen.
- The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor.
- The endoscopist will primarily rely on the second monitor (augmented with annotation from EndoVigilant ColonCAD software) but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.
- Conditions
- Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyps
- Being tested
- EndoVigilant CAD Software
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoVigilant CAD SoftwareDevice
The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system.
| Study group | Role | What they receive |
|---|---|---|
| EndoVigilant CAD Software assisted Colonoscopy Procedure | Experimental | The gastroenterologist performing the colonoscopy procedure will be able to observe a standard colonoscopy video on the primary monitor and video augmented by EndoVigilant CAD software on the second monitor. The gastroenterologist will primarily rely on the second monitor but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc. Receives: Device: EndoVigilant CAD Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenomas Per Colonoscopy
Averaged Adenomas Per Colonoscopy (APC), to determine if the use of CAD software identifies more adenomas per colonoscopy. This will be generated for the entire study as well as each investigator. This prospectively collected data will be compared against APC for same number of past procedures performed without use of EndoVigilant CAD system, both at aggregate and physician level.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Oct 2019
- Primary completion15 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoVigilant Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195646
- Sponsor's protocol ID
- EV-CS-001
- Status last verified
- Sep 2021
- First submitted
- 10 Dec 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Aided Detection of Polyps During Colonoscopy Procedures
- ClinicalTrials.gov ID
- NCT04195646
- Acronym / sponsor ID
- EV-CS-001
- Conditions
- Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- EndoVigilant IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 12 Dec 2019 (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 focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.
Detailed description
The details of the proposed study are as follows:
- Colonoscopy will be performed in the same standard of care manner as if no study was taking place. The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor. The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen.
- The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor.
- The endoscopist will primarily rely on the second monitor (augmented with annotation from EndoVigilant ColonCAD software) but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoVigilant CAD Software assisted Colonoscopy Procedure | Experimental | Device: EndoVigilant CAD SoftwareThe gastroenterologist performing the colonoscopy procedure will be able to observe a standard colonoscopy video on the primary monitor and video augmented by EndoVigilant CAD software on the second monitor. The gastroenterologist will primarily rely on the second monitor but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient presenting for routine colonoscopy for screening and/or surveillance purposes
- Ability to provide written, informed consent and understand the responsibilities of study participation
Key exclusion criteria (3 listed)
- Patients with diminished cognitive capacity
- Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis
- Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)
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 |
|---|---|---|
| EndoVigilant CAD SoftwareThe CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system. | Device | EndoVigilant CAD Software assisted Colonoscopy Procedure |
Primary outcome
Adenomas Per Colonoscopy
Time frame: 1 hour
Averaged Adenomas Per Colonoscopy (APC), to determine if the use of CAD software identifies more adenomas per colonoscopy. This will be generated for the entire study as well as each investigator. This prospectively collected data will be compared against APC for same number of past procedures performed without use of EndoVigilant CAD system, both at aggregate and physician level.
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 2 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoVigilant CAD Software in people with Colo-rectal Cancer and Polyp of Colon, run by EndoVigilant Inc at 2 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 2 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: 1 hour). 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 2 Sep 2021.