Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies (COLODETECT)
October 2, 2021 updated by: Clément Delliot, Centre Hospitalier Universitaire de Nīmes
A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone
Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :
- Colonoscopy Only Group
- Artificial intelligence only group (IA GI GENIUS ™ alone)
- Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 34000
- CHU Nîmes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients are recruited during a pre-colonoscopy consultation, carried out by the gastroenterologist in current practice
Description
Inclusion Criteria :
- 18 years < Patient < 85 years
- Need to perform a primary and / or secondary screening colonoscopy for colorectal cancer
- Patients candidates for outpatient care
Exclusion Criteria :
- History of inflammatory digestive tract disease
- Failed previous colonoscopy
- Known familial polyposis
- Biopsy / polypectomy contraindication (coagulation disorder, treatment with CLOPIDOGREL / Anticoagulant)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Colonoscopy Only Group
|
|
Artificial intelligence GI GENIUS ™ only Group
|
|
Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
Time Frame: 4 months
|
number of colonoscopies with the discovery of at least 1 colonic adenoma out of the total number of colonoscopies according to the use of colonoscopy alone / artificial intelligence alone / artificial intelligence combined with the endoscopic cap.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adenomas Rate according to their morphology
Time Frame: 4 months
|
according to Paris classification
|
4 months
|
|
Adenomas Rate according to their size
Time Frame: 4 months
|
< 0,5mm / 0-5-10mm / > 10mm
|
4 months
|
|
Adenomas Rate according to their histology
Time Frame: 4 months
|
according to Vienne classification
|
4 months
|
|
Caecal Intubation Rate
Time Frame: 4 months
|
Complete colonocopy rate
|
4 months
|
|
Withdrawal time
Time Frame: 4 months
|
4 months
|
|
|
Adverse effects
Time Frame: 4 months
|
Haemorrhages, Perforation
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 8, 2021
Study Registration Dates
First Submitted
October 2, 2021
First Submitted That Met QC Criteria
October 2, 2021
First Posted (Actual)
October 15, 2021
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 2, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.06.06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.