Colonic PolypCOLO-GENIUSNCT04440865
Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)
A study testing Genius® System-assisted Colonoscopy and Standard Colonoscopy in people with Colonic Polyp and Colonoscopy, run by Clinique Paris-Bercy at 1 site in France.
Trial summary
This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy. The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp, Colonoscopy, Artificial Intelligence
- What is being tested?
- Genius® System-assisted Colonoscopy and Standard Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 20 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for total colonoscopic exploration, during the period study
- Patient over or equal to 18 years
- ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Certificate of non opposition signed
Who cannot join
- Patient under 18 years old
- ASA 4, ASA 5
- Pregnant woman
- Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
- Patient referred for resection of a known polyp
- Inflammatory bowel disease
Show all 10Show fewer
- Known colonic stenosis
- Diverticulitis less than 6 weeks old
- Patient unable to give consent or protected by law
- Opposition expressed for inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy.
The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).
Read the detailed description
Any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited.
The patient will be offered to participate in the study. The information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits).
A period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study.
After the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. The use of the Genius® system will depend on the randomization that will be performed at the start of the colonoscopy.
This randomization will be done in the computer examination room using the randomization software.
The patient will therefore be randomized into 2 groups:
Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system will be made as following:
A-Main criterion:
- Adenoma detection rate (ADR)
B-Secondary criteria:
Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors associated with ADR
- Being tested
- Genius® System-assisted Colonoscopy, Standard Colonoscopy
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genius® System-assisted ColonoscopyOther
Genius® Intelligence System is used to assist Colonoscopy
Standard ColonoscopyOther
Standard Colonoscopy without Genius® Intelligence System is performed
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Standard colonoscopy | Active comparator | Standard colonoscopy is performed Receives: Other: Standard Colonoscopy |
| Arm 2- Colonoscopy assisted by Genius | Active comparator | Colonoscopy assisted by Genius artificial intelligence system is performed Receives: Other: Genius® System-assisted Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
percentage of colonoscopy with one or more adenoma of the colon
Measured: 1 day
Secondary outcomes (9)
Advanced Neoplasia Detection Rate (ANDR)
percentage of colonoscopy with one or more advanced neoplasia of the colon
Measured: 1 day
Proximal Serrated Polyp Detection Rate (PSPDR)
percentage of colonoscopy with one or more serrated polyp of the colon
Measured: 1 day
Polyp Detection Rate (PDR)
percentage of colonoscopy with one or more polyp of the colon
Measured: 1 day
The factors influencing the Adenoma Detection Rate (ADR)
Withdrawal time (in seconds): time of exploration from the caecum to the anal verge
Measured: 1 day
The factors influencing the Adenoma Detection Rate (ADR)
Boston scale (0 to 9)
Measured: 1 day
Time to reach caecum (sec)
Time to reach caecum from the beginning of the procedure (in seconds)
Measured: 1 day
Caecal intubation rate (%)
Caecal intubation rate (complete colonoscopy)
Measured: 1 day
Morbidity: perforation rate (%)
Perforation rates (%)
Measured: 7 days after procedure
Morbidity: bleeding rate (%)
Bleeding rates (%)
Measured: 7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Feb 2021
- Primary completion1 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
- Masking
- None (open label)
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Paris-Bercy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Karsenti, MD, Study director, Clinique Paris-Bercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440865
- Sponsor's protocol ID
- COLO-GENIUS
- Acronym
- COLO-GENIUS
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karsenti D, Tharsis G, Perrot B, Cattan P, Percie du Sert A, Venezia F, Zrihen E, Gillet A, Lab JP, Tordjman G, Cavicchi M. Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):726-734. doi: 10.1016/S2468-1253(23)00104-8. Epub 2023 Jun 1.
PubMed 37269872
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04440865
- Acronym / sponsor ID
- COLO-GENIUS / COLO-GENIUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- Clinique Paris-BercyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 22 Jun 2020 (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 controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy.
The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).
Detailed description
Any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited.
The patient will be offered to participate in the study. The information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits).
A period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study.
After the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. The use of the Genius® system will depend on the randomization that will be performed at the start of the colonoscopy.
This randomization will be done in the computer examination room using the randomization software.
The patient will therefore be randomized into 2 groups:
Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system will be made as following:
A-Main criterion:
- Adenoma detection rate (ADR)
B-Secondary criteria:
Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors associated with ADR
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Standard colonoscopy | Active comparator | Other: Standard ColonoscopyStandard colonoscopy is performed |
| Arm 2- Colonoscopy assisted by Genius | Active comparator | Other: Genius® System-assisted ColonoscopyColonoscopy assisted by Genius artificial intelligence system is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient scheduled for total colonoscopic exploration, during the period study
- Patient over or equal to 18 years
- ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Certificate of non opposition signed
Key exclusion criteria (10 listed)
- Patient under 18 years old
- ASA 4, ASA 5
- Pregnant woman
- Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
- Patient referred for resection of a known polyp
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 |
|---|---|---|
| Genius® System-assisted ColonoscopyGenius® Intelligence System is used to assist Colonoscopy | Other | Arm 2- Colonoscopy assisted by Genius |
| Standard ColonoscopyStandard Colonoscopy without Genius® Intelligence System is performed | Other | Arm 1- Standard colonoscopy |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: 1 day
percentage of colonoscopy with one or more adenoma of the colon
9 secondary outcomes
Advanced Neoplasia Detection Rate (ANDR)
Time frame: 1 day
Proximal Serrated Polyp Detection Rate (PSPDR)
Time frame: 1 day
Polyp Detection Rate (PDR)
Time frame: 1 day
The factors influencing the Adenoma Detection Rate (ADR)
Time frame: 1 day
The factors influencing the Adenoma Detection Rate (ADR)
Time frame: 1 day
Time to reach caecum (sec)
Time frame: 1 day
Caecal intubation rate (%)
Time frame: 1 day
Morbidity: perforation rate (%)
Time frame: 7 days after procedure
Morbidity: bleeding rate (%)
Time frame: 7 days after procedure
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 6 May 2022.
- Derived from this study: PubMed 37269872Karsenti D, Tharsis G, Perrot B, Cattan P, Percie du Sert A, Venezia F, Zrihen E, Gillet A, Lab JP, Tordjman G, Cavicchi M. Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):726-734. doi: 10.1016/S2468-1253(23)00104-8. Epub 2023 Jun 1.
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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.
David Karsenti, MD study director
Clinique Paris-Bercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genius® System-assisted Colonoscopy and Standard Colonoscopy in people with Colonic Polyp and Colonoscopy, run by Clinique Paris-Bercy at 1 site in France.
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 5 inclusion and 10 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 6 May 2022. 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 France. 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?
Adenoma Detection Rate (ADR) (time frame: 1 day). 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 NCT04440865, which also lists 1 linked publication.
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 6 May 2022.