Colorectal CarcinomaAIColonoscopyNCT06621225
Artificial Intelligence in Colonoscopy
A study testing Artificial Intelligence and Mucosal Exposure Device in people with Colorectal Carcinoma, run by Pankaj Patel at 1 site in United States.
Trial summary
N = 264 patients (50% female) aged 75 years and above undergoing colonoscopy were enrolled. Patients were randomly assigned into one of the three intervention groups: the primary intervention arm (CADe in combination with the MED), the second group with MED alone, and the control group with WLE. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Artificial Intelligence and Mucosal Exposure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 30 Jun 2023
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aged 75 years and older.
- Patients who were able to provide informed consent or had a legally authorized representative who can consent on their behalf.
- Patients who were deemed fit for colonoscopy based on a pre-procedure evaluation.
Who cannot join
- Patients with acute gastrointestinal conditions such as active colitis, acute diverticulitis, or bowel obstruction.
- Patients with a history of major colorectal surgery that might alter normal colon anatomy (e.g., colectomy).
- Patients with severe comorbid conditions that would contraindicate colonoscopy, such as severe cardiopulmonary disease or advanced liver disease.
- Patients with uncorrected coagulopathies or those on anticoagulation therapy that cannot be safely managed around the time of the procedure.
- Patients who are unable to adequately prepare the bowel for colonoscopy.
- Patients who refuse to participate in the study or have a legally authorized representative who refuses consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Surgery and Endoscopy Center of Sebring
Sebring, Florida, 33870
About this study
Official title: A Randomized Trial on the Utilization of Endocuff-assisted Colonoscopy and Computer-aided Detection in Optimizing Colonoscopies in the Elderly
N = 264 patients (50% female) aged 75 years and above undergoing colonoscopy were enrolled. Patients were randomly assigned into one of the three intervention groups: the primary intervention arm (CADe in combination with the MED), the second group with MED alone, and the control group with WLE. All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was the adenoma detection rate. Secondary outcomes were adenoma detection in the left colon in our cohort of patients.
Read the detailed description
264 patients, with an equal gender distribution (50% female), aged 75 years and above, undergoing screening and diagnostic colonoscopy at The Surgery and Endoscopy Center of Sebring, Sebring, Florida, were enrolled in this study. The eligibility criteria for a randomized controlled trial (RCT) comparing AI and mucosal exposure devices together, mucosal exposure devices alone, and white light endoscopy in patients 75 years and older could be structured as follows.
Patients were randomly allocated into one of three study groups: the primary intervention arm, where colonoscopy was performed using the CADe in combination with the MED; the second group underwent colonoscopy solely with the MED, while the control group underwent colonoscopy solely with the WLE. We used a Convolutional Neural Network-based CADe system, GI Genius, acquired for licensed use from Medtronic Inc., Minneapolis, MN. The MED employed was the EndoCuff Vision (ECV) developed by Olympus America, Center Valley, PA, which constitutes part of the standard equipment available. All detected lesions were identified and excised throughout the colonoscopy procedures, and specimens were promptly sent for histopathological analysis.
The primary outcome of interest was adenoma detection rate (ADR), defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy. Secondary outcomes included ADR in the left colon in our cohort of patients.
This study was conducted according to accepted ethical principles and approved by the institutional review board (IRB) of "The Surgery and Endoscopy Center of Sebring.\" Informed consent was obtained from all participants before enrollment, and measures were taken to ensure patient confidentiality and data protection throughout the study period.
- Conditions
- Colorectal Carcinoma
- Being tested
- Artificial Intelligence, Mucosal Exposure Device
- Keywords
- Colonoscopy, Mucosal Exposure Device, Artificial Intelligence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial IntelligenceDevice
Medtronic GI Genius is an advanced AI-powered platform designed to assist gastroenterologists during colonoscopies. Utilizing deep learning algorithms, it analyzes real-time endoscopic images to detect and highlight polyps and other abnormalities, enhancing the detection rate and accuracy. The system provides visual cues to guide physicians in identifying potentially problematic areas that might be missed by the human eye alone. This technology aims to improve diagnostic precision, reduce missed detections, and ultimately enhance patient outcomes by facilitating earlier and more accurate interventions. GI Genius integrates seamlessly with existing endoscopy equipment, offering a valuable tool in the fight against colorectal cancer.
Mucosal Exposure DeviceDevice
The Olympus Endocuff is an innovative device designed to enhance the effectiveness of colonoscopy procedures. It is a soft, flexible cuff that attaches to the end of the colonoscope and features multiple protruding \"fingers\" that help to improve mucosal exposure. By providing better visibility and maneuverability, the Endocuff helps gastroenterologists navigate and inspect the colon more thoroughly. It aids in the detection of polyps and other abnormalities by flattening folds and improving the overall view of the colon lining. This enhanced visualization contributes to more accurate diagnoses and can potentially reduce the miss rate of significant lesions, ultimately leading to better patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Primary Intervention Arm | Experimental | In this arm, colonoscopy was performed using Computer Aided detection in combination with a Mucosal Exposure Device, which is FDA approved. Receives: Device: Artificial Intelligence; Device: Mucosal Exposure Device |
| Secondary Intervention Arm | Experimental | In this arm, participants underwent colonoscopy solely with an FDA approved Mucosal Exposure Device Receives: Device: Mucosal Exposure Device |
| Control group | No intervention | In this arm, the participants underwent standard white light endoscopy without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The primary outcome of interest was adenoma detection rate (ADR), defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy.
Measured: 181 days
Secondary outcomes (1)
Secondary Outcome Measure
Secondary outcomes included Adenoam Detection Rate in the left colon in our cohort of patients.
Measured: 181 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start22 Nov 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies 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
- Model description
- Patients were randomly allocated into one of three study groups: the primary intervention arm, where colonoscopy was performed using the CADe in combination with the MED; the second group underwent colonoscopy solely with the MED, while the control group underwent colonoscopy solely with the WLE. Randomization was executed by a scheduler responsible for patient appointments at the practice, ensuring impartial allocation, with the investigators maintaining no involvement in subject assignment to study arms. We used a Convolutional Neural Network-based CADe system, GI Genius, acquired for licensed use from Medtronic Inc., Minneapolis, MN. The MED employed was the EndoCuff Vision (ECV) developed by Olympus America, Center Valley, PA, which constitutes part of the standard equipment available. All detected lesions were identified and excised throughout the colonoscopy procedures, and specimens were promptly sent for histopathological analysis.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pankaj Patel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pankaj Patel, The Surgery and Endoscopy Center of Sebring
- Investigators
- Pankaj J Patel, MD, Principal investigator, The Surgery and Endoscopy Center of Sebring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621225
- Sponsor's protocol ID
- Pro00069956
- Acronym
- AIColonoscopy
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual Participant Data (IPD) might not be shared in clinical trial registration for several reasons. Firstly, sharing IPD raises privacy concerns, as de-identification processes may not fully protect participants\' confidentiality. Ethical obligations to safeguard participants' sensitive health information must be upheld. Secondly, consent limitations could prevent sharing, especially if participants were not explicitly informed that their data might be shared with external parties. Additionally, proprietary concerns could restrict data sharing if the data are tied to intellectual property or are part of ongoing research. Lastly, regulatory or legal restrictions in specific regions or institutions may limit the ability to share IPD.
Publications
Pohl H, Robertson DJ. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol. 2010 Oct;8(10):858-64. doi: 10.1016/j.cgh.2010.06.028. Epub 2010 Jul 22.
PubMed 20655393Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
PubMed 31631858
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on the Utilization of Endocuff-assisted Colonoscopy and Computer-aided Detection in Optimizing Colonoscopies in the Elderly
- ClinicalTrials.gov ID
- NCT06621225
- Acronym / sponsor ID
- AIColonoscopy / Pro00069956
- Conditions
- Colorectal Carcinoma
- Keywords
- Colonoscopy, Mucosal Exposure Device, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Pankaj PatelUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Oct 2024 (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.
N = 264 patients (50% female) aged 75 years and above undergoing colonoscopy were enrolled. Patients were randomly assigned into one of the three intervention groups: the primary intervention arm (CADe in combination with the MED), the second group with MED alone, and the control group with WLE. All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was the adenoma detection rate. Secondary outcomes were adenoma detection in the left colon in our cohort of patients.
Detailed description
264 patients, with an equal gender distribution (50% female), aged 75 years and above, undergoing screening and diagnostic colonoscopy at The Surgery and Endoscopy Center of Sebring, Sebring, Florida, were enrolled in this study. The eligibility criteria for a randomized controlled trial (RCT) comparing AI and mucosal exposure devices together, mucosal exposure devices alone, and white light endoscopy in patients 75 years and older could be structured as follows.
Patients were randomly allocated into one of three study groups: the primary intervention arm, where colonoscopy was performed using the CADe in combination with the MED; the second group underwent colonoscopy solely with the MED, while the control group underwent colonoscopy solely with the WLE. We used a Convolutional Neural Network-based CADe system, GI Genius, acquired for licensed use from Medtronic Inc., Minneapolis, MN. The MED employed was the EndoCuff Vision (ECV) developed by Olympus America, Center Valley, PA, which constitutes part of the standard equipment available. All detected lesions were identified and excised throughout the colonoscopy procedures, and specimens were promptly sent for histopathological analysis.
The primary outcome of interest was adenoma detection rate (ADR), defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy. Secondary outcomes included ADR in the left colon in our cohort of patients.
This study was conducted according to accepted ethical principles and approved by the institutional review board (IRB) of "The Surgery and Endoscopy Center of Sebring.\" Informed consent was obtained from all participants before enrollment, and measures were taken to ensure patient confidentiality and data protection throughout the study period.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Patients were randomly allocated into one of three study groups: the primary intervention arm, where colonoscopy was performed using the CADe in combination with the MED; the second group underwent colonoscopy solely with the MED, while the control group underwent colonoscopy solely with the WLE. Randomization was executed by a scheduler responsible for patient appointments at the practice, ensuring impartial allocation, with the investigators maintaining no involvement in subject assignment to study arms. We used a Convolutional Neural Network-based CADe system, GI Genius, acquired for licensed use from Medtronic Inc., Minneapolis, MN. The MED employed was the EndoCuff Vision (ECV) developed by Olympus America, Center Valley, PA, which constitutes part of the standard equipment available. All detected lesions were identified and excised throughout the colonoscopy procedures, and specimens were promptly sent for histopathological analysis.
| Arm | Type | Receives |
|---|---|---|
| Primary Intervention Arm | Experimental | Device: Artificial Intelligence, Device: Mucosal Exposure DeviceIn this arm, colonoscopy was performed using Computer Aided detection in combination with a Mucosal Exposure Device, which is FDA approved. |
| Secondary Intervention Arm | Experimental | Device: Mucosal Exposure DeviceIn this arm, participants underwent colonoscopy solely with an FDA approved Mucosal Exposure Device |
| Control group | No intervention | –In this arm, the participants underwent standard white light endoscopy without any intervention. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged 75 years and older.
- Patients who were able to provide informed consent or had a legally authorized representative who can consent on their behalf.
- Patients who were deemed fit for colonoscopy based on a pre-procedure evaluation.
Key exclusion criteria (6 listed)
- Patients with acute gastrointestinal conditions such as active colitis, acute diverticulitis, or bowel obstruction.
- Patients with a history of major colorectal surgery that might alter normal colon anatomy (e.g., colectomy).
- Patients with severe comorbid conditions that would contraindicate colonoscopy, such as severe cardiopulmonary disease or advanced liver disease.
- Patients with uncorrected coagulopathies or those on anticoagulation therapy that cannot be safely managed around the time of the procedure.
- Patients who are unable to adequately prepare the bowel for colonoscopy.
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 |
|---|---|---|
| Artificial IntelligenceMedtronic GI Genius is an advanced AI-powered platform designed to assist gastroenterologists during colonoscopies. Utilizing deep learning algorithms, it analyzes real-time endoscopic images to detect and highlight polyps and other abnormalities, enhancing the detection rate and accuracy. The system provides visual cues to guide physicians in identifying potentially problematic areas that might be missed by the human eye alone. This technology aims to improve diagnostic precision, reduce missed detections, and ultimately enhance patient outcomes by facilitating earlier and more accurate interventions. GI Genius integrates seamlessly with existing endoscopy equipment, offering a valuable tool in the fight against colorectal cancer. | Device | Primary Intervention Arm |
| Mucosal Exposure DeviceThe Olympus Endocuff is an innovative device designed to enhance the effectiveness of colonoscopy procedures. It is a soft, flexible cuff that attaches to the end of the colonoscope and features multiple protruding \"fingers\" that help to improve mucosal exposure. By providing better visibility and maneuverability, the Endocuff helps gastroenterologists navigate and inspect the colon more thoroughly. It aids in the detection of polyps and other abnormalities by flattening folds and improving the overall view of the colon lining. This enhanced visualization contributes to more accurate diagnoses and can potentially reduce the miss rate of significant lesions, ultimately leading to better patient outcomes. | Device | Primary Intervention Arm, Secondary Intervention Arm |
Primary outcome
Primary Outcome Measure
Time frame: 181 days
The primary outcome of interest was adenoma detection rate (ADR), defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy.
1 secondary outcome
Secondary Outcome Measure
Time frame: 181 days
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 Oct 2024.
- Background: PubMed 20655393Pohl H, Robertson DJ. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol. 2010 Oct;8(10):858-64. doi: 10.1016/j.cgh.2010.06.028. Epub 2010 Jul 22.
- Background: PubMed 31631858Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) might not be shared in clinical trial registration for several reasons. Firstly, sharing IPD raises privacy concerns, as de-identification processes may not fully protect participants\' confidentiality. Ethical obligations to safeguard participants' sensitive health information must be upheld. Secondly, consent limitations could prevent sharing, especially if participants were not explicitly informed that their data might be shared with external parties. Additionally, proprietary concerns could restrict data sharing if the data are tied to intellectual property or are part of ongoing research. Lastly, regulatory or legal restrictions in specific regions or institutions may limit the ability to share IPD.
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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.
Pankaj J Patel, MD principal investigator
The Surgery and Endoscopy Center of Sebring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence and Mucosal Exposure Device in people with Colorectal Carcinoma, run by Pankaj Patel 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 1 Oct 2024. 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?
Primary Outcome Measure (time frame: 181 days). 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 NCT06621225, which also lists 2 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 1 Oct 2024.