CB-17-08 Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.
Completed · Not applicable
Conditions studied: Colorectal Cancer
In brief
The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard colonoscopy alone: the study will investigate whether the use of the device provides an increase in the number of adenomas per colonoscopy as compared to standard colonoscopy. The study will also evaluate the safety of the CB-17-08, assessing if the use of the system increases the total number of excisions without a commensurate number of adenomas as compared to standard colonoscopy.
Key facts
- Study ID
- NCT03954548
- Run by
- Cosmo Artificial Intelligence-AI Ltd
- People needed
- 249
- Starts
- 2020-02-17
- Expected to finish
- 2021-05-07
- Last updated by the study team
- 2021-05-12
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male and female patients age: ≥45 years;
- Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy for CRC;
- Willingness to undergo tandem colonoscopies with and without the use of CB-17-08 on the same day and in the same procedural setting;
- Ability to provide written, informed consent and understand the responsibilities of trial participation;
You may not qualify if…
- The subject is pregnant or is planning a pregnancy during the study period;
- History of inflammatory bowel disease (IBD);
- History of colon resection;
- History of Familial adenomatous polyposis (FAP) syndrome or of Serrated Polyposis Syndrome (SPS);
- History of overt lower GI bleeding;
- History of colonic stricture;
- History of radiation therapy to the abdomen or pelvis;
- Patients with contraindications to colonoscopy such as presence of acute diverticulitis or toxic megacolon;
- Subjects with particular symptoms (e.g diarrhea) who, per clinical practice, have to undergo random biopsies in the colon.
- Fecal Occult Blood Test (FOBT) or Fecal Immunochemical Test (FIT) positive patients will not be excluded from the study.
Where it is running
- Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
- Geisinger Medical Center — Danville, California, United States
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- Kansas City VA Medical Center — Kansas City, Kansas, United States
- Ascension St. John's Hospital — Detroit, Michigan, United States
- Mayo Clinic Eau Claire — Eau Claire, Wisconsin, United States
- Mayo Clinic La Crosse — La Crosse, Wisconsin, United States
- ASL Roma 1 (Presidio Nuova regina Margherita) — Roma, Italy
- Queen Alexandra Hospital — Cosham, United Kingdom
- Oxford University Hospitals — Oxford, United Kingdom
Full record on ClinicalTrials.gov
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