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OpenTrials
Completed

NCT Number: NCT05080088

Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

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)

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Key information

Conditions

Adenoma Colon Colonic Adenocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Colorectal Polyp Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nîmes

Nîmes, Gard, 34000, France

Who can participate

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

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adenomas Rate according to their morphology

    Time frame: 4 months

    according to Paris classification

  2. Adenomas Rate according to their size

    Time frame: 4 months

    < 0,5mm / 0-5-10mm / > 10mm

  3. Adenomas Rate according to their histology

    Time frame: 4 months

    according to Vienne classification

  4. Caecal Intubation Rate

    Time frame: 4 months

    Complete colonocopy rate

  5. Withdrawal time

    Time frame: 4 months

  6. Adverse effects

    Time frame: 4 months

    Haemorrhages, Perforation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: COLODETECT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2021
Registry last updated
Oct 15, 2021

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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