Adenoma ColonCOLODETECTNCT05080088
Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies
An observational study of Adenoma Colon and Colorectal Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adenoma Colon, Colorectal Cancer, Colorectal Polyp
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2021to 8 Jul 2021
- Phase
- Observational
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: patients are recruited during a pre-colonoscopy consultation, carried out by the gastroenterologist in current practice
Who may be able to join
- 18 years < Patient < 85 years
- Need to perform a primary and / or secondary screening colonoscopy for colorectal cancer
- Patients candidates for outpatient care
Who cannot join
- History of inflammatory digestive tract disease
- Failed previous colonoscopy
- Known familial polyposis
- Biopsy / polypectomy contraindication (coagulation disorder, treatment with CLOPIDOGREL / Anticoagulant)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy Only Group | Not described | |
| Artificial intelligence GI GENIUS ™ only Group | Not described | |
| Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
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.
Measured: 4 months
Secondary outcomes (6)
Adenomas Rate according to their morphology
according to Paris classification
Measured: 4 months
Adenomas Rate according to their size
< 0,5mm / 0-5-10mm / > 10mm
Measured: 4 months
Adenomas Rate according to their histology
according to Vienne classification
Measured: 4 months
Caecal Intubation Rate
Complete colonocopy rate
Measured: 4 months
Withdrawal time
Measured: 4 months
Adverse effects
Haemorrhages, Perforation
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start6 Apr 2021
- Primary completion1 Jul 2021
- Study completion8 Jul 2021
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 Adenoma ColonStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clément Delliot, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080088
- Sponsor's protocol ID
- 21.06.06
- Acronym
- COLODETECT
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caillo L, Delliot C, Chevallier T, Bourgaux JF, Prost A, Brunaud-Gagniard B, Phoutthasang V, Clerc C, Borderie T, Daniel J, Pouderoux P, Debourdeau A. COLODETECT 1: comparative evaluation of endocuff with computer-aided detection versus computer-aided detection alone versus standard colonoscopy for enhancing adenoma detection rates during screening colonoscopy-a pilot study. Ther Adv Gastroenterol. 2024 Oct 27;17:17562848241290433. doi: 10.1177/17562848241290433. eCollection 2024.
PubMed 39493261
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05080088
- Acronym / sponsor ID
- COLODETECT / 21.06.06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 15 Oct 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy Only Group | – | – |
| Artificial intelligence GI GENIUS ™ only Group | – | – |
| Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients are recruited during a pre-colonoscopy consultation, carried out by the gastroenterologist in current practice
Key inclusion criteria (3 listed)
- 18 years < Patient < 85 years
- Need to perform a primary and / or secondary screening colonoscopy for colorectal cancer
- Patients candidates for outpatient care
Key exclusion criteria (4 listed)
- History of inflammatory digestive tract disease
- Failed previous colonoscopy
- Known familial polyposis
- Biopsy / polypectomy contraindication (coagulation disorder, treatment with CLOPIDOGREL / Anticoagulant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Adenomas Rate according to their morphology
Time frame: 4 months
Adenomas Rate according to their size
Time frame: 4 months
Adenomas Rate according to their histology
Time frame: 4 months
Caecal Intubation Rate
Time frame: 4 months
Withdrawal time
Time frame: 4 months
Adverse effects
Time frame: 4 months
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 15 Oct 2021.
- Derived from this study: PubMed 39493261Caillo L, Delliot C, Chevallier T, Bourgaux JF, Prost A, Brunaud-Gagniard B, Phoutthasang V, Clerc C, Borderie T, Daniel J, Pouderoux P, Debourdeau A. COLODETECT 1: comparative evaluation of endocuff with computer-aided detection versus computer-aided detection alone versus standard colonoscopy for enhancing adenoma detection rates during screening colonoscopy-a pilot study. Ther Adv Gastroenterol. 2024 Oct 27;17:17562848241290433. doi: 10.1177/17562848241290433. eCollection 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma Colon and Colorectal Cancer, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 4 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 15 Oct 2021. 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?
Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software (time frame: 4 months). 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 NCT05080088, 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 15 Oct 2021.