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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Overview

Información sobre este estudio

The purpose of this research is to evaluate the accuracy of a medical device that has been developed to automatically find polyps (small growths) during colonoscopies. The device uses a computer to detect and highlight potential polyps from the usual video images made during a colonoscopy, and such detections will be visible to  the doctor during the regular colonoscopy procedure. This medical device is called Endoscopy Video Assistance for Colonoscopy (EVA-C). EVA-C, an investigational device, has been developed to assist the doctor in identifying possible polyps, but is not meant to replace their decision making. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥ years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
  • Between the ages of 45 and 80 years, inclusive.
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • Self-reported pregnancy.
  • Known diagnosis of Colorectal Cancer.
  • History of, or referral for, Inflammatory Bowel Disease.
  • Previous surgery involving the colon or rectum.
  • Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
  • High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
  • Referral for overt, symptomatic gastrointestinal bleeding.

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Cadman Leggett, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20536228

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