Colon Cancer Clinical Trial
— AIRCOPOfficial title:
Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection: a Randomized Controlled Trial
Verified date | March 2023 |
Source | Groupe Hospitalier Diaconesses Croix Saint-Simon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon). To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence software connected to the machine. This software does not modify the colonoscopy technique in any way, and does not require the administration of any product to the patient. The study will compare the detection rate of right colon polyps between the group of patients who underwent standard colonoscopy and those who underwent colonoscopy with artificial intelligence. If this number does not differ between the two groups, the investigators can conclude that there is no point in using artificial intelligence.
Status | Completed |
Enrollment | 2000 |
Est. completion date | January 3, 2024 |
Est. primary completion date | December 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age>18 years - Signed informed consent - Affiliated to or beneficiary of a social security scheme Exclusion Criteria: - Patients with history of inflammatory bowel diseases - Patients with history of familial polyposis syndrome - Patients with history of right colonic resection. - Pregnant or breastfeeding women - Patient benefiting from a legal protection measure : tutorship, curatorship, patient deprived of freedom - Adults who are unable to give their consent - People under psychiatric care who are not able to understand the aim if this research |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Diaconesses Croix Saint-Simon | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Diaconesses Croix Saint-Simon | Cosmo Artificial Intelligence-AI Ltd |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale, for the operator, for the endoscope and for stratification factors. | A multiple logistic regression comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale (6-7 vs >7), for the operator, for the endoscope (Pentax or Fuji) and for stratification factors (age and polyps or CRC history). | Inclusion visit |
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