Colorectal (Colon or Rectal) CancerNCT05317351
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
A study testing Standard Colonoscopy, Artificial Intelligence Aided Colonoscopy (GI Genius™) and Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy in people with Colorectal (Colon or Rectal) Cancer and Adenoma, run by Smart Medical Systems Ltd. at 2 sites in United States.
Trial summary
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer, Adenoma
- What is being tested?
- Standard Colonoscopy, Artificial Intelligence Aided Colonoscopy (GI Genius™) and Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,160 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2022to Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of age ≥ 45 years old
- Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)
- The patient must understand and provide written consent for the procedure.
Who cannot join
- Subjects with inflammatory bowel disease
- Subjects with a personal history of polyposis syndrome
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy
- Subjects with diverticulitis or toxic megacolon
- Subjects with a history of radiation therapy to abdomen or pelvis
- Pregnant or lactating female subjects
Show all 11Show fewer
- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 46202
Douglas K Rex, MD, 317-777-9676, drex@iu.edu
NYU Langone Health
New York, New York, 10016
Seth A Gross, MD, 212-263-3095, Seth.Gross@nyulangone.org
About this study
Official title: A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:
(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Read the detailed description
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:
(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.
- Conditions
- Colorectal (Colon or Rectal) Cancer, Adenoma
- Being tested
- Standard Colonoscopy, Artificial Intelligence Aided Colonoscopy (GI Genius™), Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
- Medical subject headings
- Colonic Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ColonoscopyDevice
Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope
Artificial Intelligence Aided Colonoscopy (GI Genius™)Device
Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided ColonoscopyDevice
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy ("SC") | Active comparator | Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope. Receives: Device: Standard Colonoscopy |
| Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI") | Active comparator | Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) Receives: Device: Artificial Intelligence Aided Colonoscopy (GI Genius™) |
| Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG) | Experimental | Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). Receives: Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Per Colonoscopy (APC) (AI compared with AG)
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.
Measured: Upon histology results (up to 30 days)
Secondary outcomes (2)
Adenoma Per Colonoscopy (APC) (SC compared with AG)
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG
Measured: Upon histology results (up to 30 days)
Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)
Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG
Measured: Upon histology results (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy, (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
- Masking
- None (open label)
- Enrolment
- 2,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglad K Rex, MD, Principal investigator, Indina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317351
- Sponsor's protocol ID
- G-EYE15080
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy
- ClinicalTrials.gov ID
- NCT05317351
- Acronym / sponsor ID
- G-EYE15080
- Conditions
- Colorectal (Colon or Rectal) Cancer, Adenoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,160 participants (estimated)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Apr 2022 (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.
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:
(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Detailed description
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:
(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy, (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy ("SC") | Active comparator | Device: Standard ColonoscopySubjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope. |
| Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI") | Active comparator | Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) |
| Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG) | Experimental | Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided ColonoscopySubjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age ≥ 45 years old
- Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)
- The patient must understand and provide written consent for the procedure.
Key exclusion criteria (11 listed)
- Subjects with inflammatory bowel disease
- Subjects with a personal history of polyposis syndrome
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy
- Subjects with diverticulitis or toxic megacolon
- Subjects with a history of radiation therapy to abdomen or pelvis
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 ColonoscopySubjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope | Device | Standard Colonoscopy ("SC") |
| Artificial Intelligence Aided Colonoscopy (GI Genius™)Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) | Device | Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI") |
| Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided ColonoscopySubjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). | Device | Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG) |
Primary outcome
Adenoma Per Colonoscopy (APC) (AI compared with AG)
Time frame: Upon histology results (up to 30 days)
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.
2 secondary outcomes
Adenoma Per Colonoscopy (APC) (SC compared with AG)
Time frame: Upon histology results (up to 30 days)
Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)
Time frame: Upon histology results (up to 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Colorectal (Colon or Rectal) Cancer
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingObservational study
Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
Peritoneal (Metastatic) Cancer, Colorectal Cancer
RecruitingPhase 2
Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment, A Phase II Study
Refractory Metastatic Colorectal Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Active, not recruitingPhase 3
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
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.
Douglad K Rex, MD principal investigator
Indina University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Colonoscopy, Artificial Intelligence Aided Colonoscopy (GI Genius™) and Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy in people with Colorectal (Colon or Rectal) Cancer and Adenoma, run by Smart Medical Systems Ltd. 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douglas K Rex, MD (317-777-9676, drex@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Per Colonoscopy (APC) (AI compared with AG) (time frame: Upon histology results (up to 30 days)). 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 7 Apr 2022.