Colonic DiseasesNCT04074577
Computer Aided Detection, Tandem Colonoscopy Study
A study testing Standard technique First and combination technique First in people with Colonic Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- Standard technique First and combination technique First
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 14 Oct 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy
- Willingness to undergo tandem colonscopies with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
- Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
Who cannot join
- People with diminished cognitive capacity
- Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
- Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
- Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
- Patients with inflammatory bowel disease
- Patients referred for endoscopic mucosal resection (EMR)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.
- Conditions
- Colonic Diseases
- Being tested
- Standard technique First, combination technique First
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard technique FirstDiagnostic test
colonoscopy without automated polyp detection software
combination technique FirstDiagnostic test
automated polyp detection software
| Study group | Role | What they receive |
|---|---|---|
| Standard Technique followed by Combination | Active comparator | Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. The first colonoscopy will be performed without automated polyp detection software (standard technique) followed immediately by another colonoscopy with automated polyp detection software (combination technique). Receives: Diagnostic Test: Standard technique First |
| Combination +followed by Standard Technique | Active comparator | Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. In this arm, the first colonoscopy with be performed with automated polyp detection software (combination technique) followed immediately by another colonoscopy without automated polyp detection software (standard technique) Receives: Diagnostic Test: combination technique First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)
AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start17 Sep 2020
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Gross, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074577
- Sponsor's protocol ID
- 19-00801
- Status last verified
- Jun 2021
- First submitted
- 29 Aug 2019
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Aided Detection, Tandem Colonoscopy Study
- ClinicalTrials.gov ID
- NCT04074577
- Acronym / sponsor ID
- 19-00801
- Conditions
- Colonic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 30 Aug 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 purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Technique followed by Combination | Active comparator | Diagnostic Test: Standard technique FirstBack-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. The first colonoscopy will be performed without automated polyp detection software (standard technique) followed immediately by another colonoscopy with automated polyp detection software (combination technique). |
| Combination +followed by Standard Technique | Active comparator | Diagnostic Test: combination technique FirstBack-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. In this arm, the first colonoscopy with be performed with automated polyp detection software (combination technique) followed immediately by another colonoscopy without automated polyp detection software (standard technique) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy
- Willingness to undergo tandem colonscopies with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
- Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
Key exclusion criteria (6 listed)
- People with diminished cognitive capacity
- Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
- Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
- Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
- Patients with inflammatory bowel disease
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 |
|---|---|---|
| Standard technique Firstcolonoscopy without automated polyp detection software | Diagnostic test | Standard Technique followed by Combination |
| combination technique Firstautomated polyp detection software | Diagnostic test | Combination +followed by Standard Technique |
Primary outcome
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)
Time frame: 1 Year
AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes.
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 29 Jun 2021.
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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.
Seth Gross, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard technique First and combination technique First in people with Colonic Diseases, run by NYU Langone Health 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 3 inclusion and 6 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 29 Jun 2021. 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?
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?
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR) (time frame: 1 Year). 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 29 Jun 2021.