CB-17-08 Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.
Prospective, Randomized, Multicenter, Tandem Study Evaluating the Safety and Effectiveness of the CB-17-08 Augmented Endoscopy System for the Detection of Mucosal Colorectal Polyps in Adult Patients Undergoing Screening or Surveillance Colonoscopy for CRC.
1 other identifier
interventional
249
3 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Feb 2020
Shorter than P25 for not_applicable colorectal-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2021
CompletedMay 12, 2021
May 1, 2021
1.2 years
May 15, 2019
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adenoma miss rate [AMR]
AMR, defined as the number of histologically confirmed adenomas and carcinomas detected during the second colonoscopy divided by the total number of histologically confirmed adenomas and carcinomas detected during the first and second colonoscopy combined.
Day 1
Secondary Outcomes (1)
Polyp Miss Rate [PMR]
Day 1
Study Arms (2)
With CB-17-08 CADe
EXPERIMENTALWithout CB-17-08 CADe
NO INTERVENTIONInterventions
CB-17-08 Augmented Endoscopy System with Computer Aided Detection (CADe) function
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Geisinger Medical Center
Danville, California, 17822, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Kansas City VA Medical Center
Kansas City, Kansas, 64128, United States
Ascension St. John's Hospital
Detroit, Michigan, 48236, United States
Mayo Clinic Eau Claire
Eau Claire, Wisconsin, 54703, United States
Mayo Clinic La Crosse
La Crosse, Wisconsin, 54601, United States
ASL Roma 1 (Presidio Nuova regina Margherita)
Roma, 00153, Italy
Queen Alexandra Hospital
Cosham, PO6 3LY, United Kingdom
Oxford University Hospitals
Oxford, OX4 2PG, United Kingdom
Related Publications (1)
Wallace MB, Sharma P, Bhandari P, East J, Antonelli G, Lorenzetti R, Vieth M, Speranza I, Spadaccini M, Desai M, Lukens FJ, Babameto G, Batista D, Singh D, Palmer W, Ramirez F, Palmer R, Lunsford T, Ruff K, Bird-Liebermann E, Ciofoaia V, Arndtz S, Cangemi D, Puddick K, Derfus G, Johal AS, Barawi M, Longo L, Moro L, Repici A, Hassan C. Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007. Epub 2022 Mar 15.
PMID: 35304117DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 17, 2019
Study Start
February 17, 2020
Primary Completion
May 7, 2021
Study Completion
May 7, 2021
Last Updated
May 12, 2021
Record last verified: 2021-05