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Trial Title:
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
NCT ID:
NCT06305364
Condition:
Colorectal Neoplasms
Gastrointestinal Microbiome
Conditions: Official terms:
Colorectal Neoplasms
Adenomatous Polyps
Conditions: Keywords:
Artificial Intelligence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Masking description:
Gastroenterologist performing standard of care colonoscopy post Gixam test will be
blinded to the Gixam prediction score.
Intervention:
Intervention type:
Device
Intervention name:
Gixam
Description:
Participants will be required to extend their tongue in the Gixam device. Six images will
be obtained and analyzed by the artificial intelligence (AI) model generating a
prediction score for the presence of colorectal adenoma.
Arm group label:
Gixam followed by standard of care colonoscopy
Summary:
This is a prospective, multicenter, single-arm clinical investigation designed to
evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal
adenomas compared to optical colonoscopy. Subjects arriving for a standard of care
colonoscopy at the investigation site will be offered to participate in the study.
Following an informed consent process, images of the subjects' tongue will be obtained
with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model.
Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be
compare with colonoscopy findings to evaluate its performance.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males or females
2. Age: 18-75 years, inclusive
3. Scheduled for colonoscopy procedure at investigation site subject to one of the
below criteria:
1. Screening - defined as first colonoscopy or consecutive colonoscopy without
previous findings, previous colonoscopy performed at least 10 years ago (- 1
year);
2. Patient with finding of colorectal adenoma or sessile serrated polyp in
previous colonoscopy (must be documented in patient's medical history).
4. Able to comprehend and provide informed consent.
Exclusion Criteria:
1. Subject who is not a suitable candidate for a colonoscopy
2. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
3. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis)
of significant duration
4. Patients with a disability to extend their tongue.
5. Patients with tongue piercings.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Peter Emanuel
Phone:
212-263-6340
Email:
peter.emanuel@nyulangone.org
Facility:
Name:
Westside GI
Address:
City:
New York
Zip:
10019
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theodore Bortz
Facility:
Name:
NewYork-Presbyterian / Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elissa Lynch
Contact backup:
Last name:
Daniel Freedberg, MD
Start date:
August 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Jubaan Ltd.
Agency class:
Industry
Source:
Jubaan Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06305364
https://jubaan.com/