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OpenTrials
Completed

NCT Number: NCT04440865

Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)

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).

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Genius® System-assisted Colonoscopy

Other

Genius® Intelligence System is used to assist Colonoscopy

Standard colonoscopy

Other

Standard Colonoscopy without Genius® Intelligence System is performed

Primary outcomes

  1. Adenoma Detection Rate (ADR)

    Time frame: 1 day

    percentage of colonoscopy with one or more adenoma of the colon

Secondary outcomes

  1. Advanced Neoplasia Detection Rate (ANDR)

    Time frame: 1 day

    percentage of colonoscopy with one or more advanced neoplasia of the colon

  2. Proximal Serrated Polyp Detection Rate (PSPDR)

    Time frame: 1 day

    percentage of colonoscopy with one or more serrated polyp of the colon

  3. Polyp Detection Rate (PDR)

    Time frame: 1 day

    percentage of colonoscopy with one or more polyp of the colon

  4. The factors influencing the Adenoma Detection Rate (ADR)

    Time frame: 1 day

    Withdrawal time (in seconds): time of exploration from the caecum to the anal verge

  5. The factors influencing the Adenoma Detection Rate (ADR)

    Time frame: 1 day

    Boston scale (0 to 9)

  6. Time to reach caecum (sec)

    Time frame: 1 day

    Time to reach caecum from the beginning of the procedure (in seconds)

  7. Caecal intubation rate (%)

    Time frame: 1 day

    Caecal intubation rate (complete colonoscopy)

  8. Morbidity: perforation rate (%)

    Time frame: 7 days after procedure

    Perforation rates (%)

  9. Morbidity: bleeding rate (%)

    Time frame: 7 days after procedure

    Bleeding rates (%)

Sponsors and collaborators

Lead sponsor

Clinique Paris-Bercy

Other

Registry information

Official study title

Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial

Acronym: COLO-GENIUS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2020
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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