A Study to Evaluate the Safety and Effectiveness of the Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-007492
- Eau Claire, Wisconsin: 19-007492
- Scottsdale/Phoenix, Arizona: 19-007492
- La Crosse, Wisconsin: 19-007492
NCT ID: NCT03954548
Sponsor Protocol Number: CB-17-08/03
About this study
The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or females, aged ≥ 45 years of age.
- Scheduled for screening or surveillance colonoscopy for CRC prevention.
- Willingness to undergo tandem colonscopies with and without the use of CADe system CB-17-08.
- Able to comprehend the full nature and purpose of the study and provide signed written informed consent.
Exclusion Criteria:
- Patients who are pregnant or are planning pregnancy during study period.
- Patients with known history of colonic resection, radiation therapy to the abdomen or pelvis, colonic stricture, Inflammatory Bowel Disease (IBD), acute diverticulitis, lower gastrointestinal bleeding, Familial Adenomatous Polyposis (FAP), or toxic megacolon will be excluded.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Michael Wallace, M.D. |
Closed for enrollment |
|
Eau Claire, Wis.
Mayo Clinic principal investigator Gregory Derfus, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Francisco Ramirez, M.D. |
Closed for enrollment |
|
La Crosse, Wis.
Mayo Clinic principal investigator Davinder Singh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available