Colorectal AdenomaAIDANCT04196088
To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age
A study testing Ultivision Artificial Intelligence Software and No Artificial Intelligence Software enhancement in people with Colorectal Adenoma and Colorectal Polyp, run by Docbot, Inc. at 9 sites in United States.
Trial summary
The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Polyp, Colorectal Adenocarcinoma
- What is being tested?
- Ultivision Artificial Intelligence Software and No Artificial Intelligence Software enhancement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 978 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Jun 2020to Dec 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Primary Inclusion Criteria.
- Average risk asymptomatic subjects undergoing a first colonoscopy (screening) or screening colonoscopy at least 10 years after prior colonoscopy.
- Aged 45 years to aged 75 years at the time of enrollment.
- Capable of providing written informed consent and willing and able to adhere to all protocol requirements, and/or the subject's legally acceptable representative(s) capable of providing written informed consent.
Primary Exclusion Criteria.
- History of any colorectal cancer or colon adenomas.
- History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis.
- Family history of colon cancer or precancerous colon polyp in a first degree relative before age 50.
- Polyposis syndromes including Familial Adenomatous Polyposis, Cowden syndrome, Lynch syndrome, Peutz-Jeghers syndrome, MUTYH Associated Polyposis, Familial Colorectal Cancer Type X.
- Surveillance, therapeutic, preoperative, or diagnostic colonoscopy.
- Colonoscopy for work-up of abdominal or pelvic symptoms including abdominal pain, flank pain, pelvic pain, subject report of altered stool, subject report of anemia within the past 12 months, subject report of gastrointestinal bleeding including bright red blood per rectum or tarry stools, constipation, diarrhea, subject reported history of abdominal or pelvic mass, subject report of unintentional weight loss.
- Workup or referral to diagnose or evaluate abnormal imaging of the abdomen or pelvis.
- Positive Fecal Immunochemical Test history.
- Severe co-mobordity, including end-stage cardiovascular, pulmonary, liver, or renal disease.
- History of colon resection, not including the appendix.
- Currently receiving a therapy not permitted during the trial, as defined in Section 8.3.
- Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the trial.
Enrolled subjects will be eligible for Post-procedure Periods if their colonoscopy meets the following criteria:
- Adequate bowel preparation score per the Boston Bowel Preparation Scoring System (BBPS) > or equal to 2 in all colonic segments.
- Colonoscopies with successful cecal intubation.
- Colonoscopies with withdrawal times of at least 6 minutes.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Gastro Health
Birmingham, Alabama, 35209
Robert Shaffer, MD, robertshaffer@hotmail.com
- Recruiting
Capital Digestive Care
Chevy Chase, Maryland, 20815
Louis Y Korman, MD, 240-737-0085, louis.korman@capitaldigestivecare.com
- Recruiting
Verity Research Inc., Gastro Health
Fairfax, Virginia, 22031
Dana Zahid, 703-776-1795, dzahid@gastrohealth.com
Joon Lee, 703-776-1795, jlee@gastrohealth.com
- Recruiting
Kansas City Veterans Administration
Kansas City, Kansas, 66103
Prateek Sharma, MD, 816-861-4700, psharma@kumc.edu
April Higbee, april.higbee@va.gov
- Recruiting
Great Lakes Gastroenterology Research, LLC, Clinical Trials Network
Mentor, Ohio, 44060
Cortney Vazquez, cvazquez@thectnx.com
Keith Friedenberg, MD
- Recruiting
Wisconsin GI Associates
Milwaukee, Wisconsin, 53215
Nalini Guda, MD, 414-908-6503, nguda@wisc.edu
- Recruiting
East Side Endoscopy
New York, New York, 10010
Ira Breite, MD, 212-375-1065
Natalie Neri, RN, 212-375-1065
- Recruiting
Gastrointestinal & Liver Specialists of Tidewater, PLLC
Norfolk, Virginia, 23502
David Johnson, MD, dajevms@aol.com
- Recruiting
Precision Research Institute
San Diego, California, 92114
Josie Summers, 619-501-0371, josie@prisandiego.com
Cristina Ortega, 619-501-0371, Cristina@prisandiego.com
About this study
Official title: AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy
The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.
- Being tested
- Ultivision Artificial Intelligence Software, No Artificial Intelligence Software enhancement
- Keywords
- screening colonoscopy, artificial intelligence, software as a medical device, adenoma detection rate, adenomas per endoscopy, mean adenomas per colonoscopy, colorectal cancer, 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.
Ultivision Artificial Intelligence SoftwareDevice
Screening Colonoscopy
No Artificial Intelligence Software enhancementDevice
Screening Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Ultivision AI Software enhanced screening colonoscopy | Active comparator | Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed. Receives: Device: Ultivision Artificial Intelligence Software |
| No AI enhancement screening colonoscopy | Placebo comparator | Screening colonoscopies without Artificial Intelligence enhancement will be performed. Receives: Device: No Artificial Intelligence Software enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall adenoma detection, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
The primary efficacy endpoint is the mean adenomas per colonoscopy procedure (MAP) detection, as defined by the protocol, with Ultivision AI software enhancement to screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Measured: through study completion, an average of 1 year
Overall adenomas per extraction, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard hiigh definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
The primary safety endpoint is the adenomas per extraction per colonoscopy procedure (APE), as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus SHDWLC without AI.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Adenoma detection rate, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
The secondary efficacy endpoint is the adenoma detection rate (ADR) defined as the ratio of screening colonoscopies with at least one adenoma, as defined by the protocol, detected divided by the total number of screening SHDWLC performed with Ultivision AI versus screening SHDWLC performed without AI.
Measured: through study completion, an average of 1 year
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 start11 Jun 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies 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
- 978 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Docbot, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Efren Rael, MD, Study director, Docbot, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196088
- Sponsor's protocol ID
- Docbot AIDA: Ultivision_002
- Acronym
- AIDA
- Status last verified
- Mar 2021
- First submitted
- 9 Dec 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
PubMed 22356322Brenner H, Chang-Claude J, Seiler CM, Rickert A, Hoffmeister M. Protection from colorectal cancer after colonoscopy: a population-based, case-control study. Ann Intern Med. 2011 Jan 4;154(1):22-30. doi: 10.7326/0003-4819-154-1-201101040-00004.
PubMed 21200035Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
PubMed 8247072Shergill AK, Conners EE, McQuaid KR, Epstein S, Ryan JC, Shah JN, Inadomi J, Somsouk M. Protective association of colonoscopy against proximal and distal colon cancer and patterns in interval cancer. Gastrointest Endosc. 2015 Sep;82(3):529-37.e1. doi: 10.1016/j.gie.2015.01.053. Epub 2015 May 1.
PubMed 25936449Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
PubMed 19075198Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
PubMed 22826281Singh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20.
PubMed 20600026Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.
PubMed 24693890Coe SG, Wallace MB. Assessment of adenoma detection rate benchmarks in women versus men. Gastrointest Endosc. 2013 Apr;77(4):631-5. doi: 10.1016/j.gie.2012.12.001. Epub 2013 Feb 1.
PubMed 23375528Adler J, Robertson DJ. Interval Colorectal Cancer After Colonoscopy: Exploring Explanations and Solutions. Am J Gastroenterol. 2015 Dec;110(12):1657-64; quiz 1665. doi: 10.1038/ajg.2015.365. Epub 2015 Nov 10.
PubMed 26553207Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
PubMed 20463339le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
PubMed 23744612Ahn SB, Han DS, Bae JH, Byun TJ, Kim JP, Eun CS. The Miss Rate for Colorectal Adenoma Determined by Quality-Adjusted, Back-to-Back Colonoscopies. Gut Liver. 2012 Jan;6(1):64-70. doi: 10.5009/gnl.2012.6.1.64. Epub 2012 Jan 12.
PubMed 22375173van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
PubMed 16454841Rex DK. Maximizing detection of adenomas and cancers during colonoscopy. Am J Gastroenterol. 2006 Dec;101(12):2866-77. doi: 10.1111/j.1572-0241.2006.00905.x.
PubMed 17227527
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT04196088
- Acronym / sponsor ID
- AIDA / Docbot AIDA: Ultivision_002
- Keywords
- screening colonoscopy, artificial intelligence, software as a medical device, adenoma detection rate, adenomas per endoscopy, mean adenomas per colonoscopy, colorectal cancer, medical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 978 participants (estimated)
- Lead sponsor
- Docbot, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- 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 aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultivision AI Software enhanced screening colonoscopy | Active comparator | Device: Ultivision Artificial Intelligence SoftwareUltivision Artificial Intelligence enhanced screening colonoscopies will be performed. |
| No AI enhancement screening colonoscopy | Placebo comparator | Device: No Artificial Intelligence Software enhancementScreening colonoscopies without Artificial Intelligence enhancement will be performed. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ultivision Artificial Intelligence SoftwareScreening Colonoscopy | Device | Ultivision AI Software enhanced screening colonoscopy |
| No Artificial Intelligence Software enhancementScreening Colonoscopy | Device | No AI enhancement screening colonoscopy |
Primary outcome
Overall adenoma detection, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time frame: through study completion, an average of 1 year
The primary efficacy endpoint is the mean adenomas per colonoscopy procedure (MAP) detection, as defined by the protocol, with Ultivision AI software enhancement to screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Overall adenomas per extraction, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard hiigh definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time frame: through study completion, an average of 1 year
The primary safety endpoint is the adenomas per extraction per colonoscopy procedure (APE), as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus SHDWLC without AI.
1 secondary outcome
Adenoma detection rate, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 22356322Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
- Background: PubMed 21200035Brenner H, Chang-Claude J, Seiler CM, Rickert A, Hoffmeister M. Protection from colorectal cancer after colonoscopy: a population-based, case-control study. Ann Intern Med. 2011 Jan 4;154(1):22-30. doi: 10.7326/0003-4819-154-1-201101040-00004.
- Background: PubMed 8247072Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
- Background: PubMed 25936449Shergill AK, Conners EE, McQuaid KR, Epstein S, Ryan JC, Shah JN, Inadomi J, Somsouk M. Protective association of colonoscopy against proximal and distal colon cancer and patterns in interval cancer. Gastrointest Endosc. 2015 Sep;82(3):529-37.e1. doi: 10.1016/j.gie.2015.01.053. Epub 2015 May 1.
- Background: PubMed 19075198Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
- Background: PubMed 22826281Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
- Background: PubMed 20600026Singh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20.
- Background: PubMed 24693890Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.
- Background: PubMed 23375528Coe SG, Wallace MB. Assessment of adenoma detection rate benchmarks in women versus men. Gastrointest Endosc. 2013 Apr;77(4):631-5. doi: 10.1016/j.gie.2012.12.001. Epub 2013 Feb 1.
- Background: PubMed 26553207Adler J, Robertson DJ. Interval Colorectal Cancer After Colonoscopy: Exploring Explanations and Solutions. Am J Gastroenterol. 2015 Dec;110(12):1657-64; quiz 1665. doi: 10.1038/ajg.2015.365. Epub 2015 Nov 10.
- Background: PubMed 20463339Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
- Background: PubMed 23744612le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
- 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.
Efren Rael, MD study director
Docbot, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultivision Artificial Intelligence Software and No Artificial Intelligence Software enhancement in people with Colorectal Adenoma and Colorectal Polyp, run by Docbot, Inc. at 9 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?
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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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?
Contact Efren Rael, MD (7179030979, efren.rael@docbot.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall adenoma detection, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI. (time frame: through study completion, an average of 1 year). 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 NCT04196088, which also lists 35 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 19 Mar 2021.