Colorectal NeoplasmsNCT06305364
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
A study testing Gixam in people with Colorectal Neoplasms and Gastrointestinal Microbiome, run by Jubaan Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Gastrointestinal Microbiome
- What is being tested?
- Gixam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females
- Age: 18-75 years, inclusive
- Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:
- Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year);
- Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history).
- Able to comprehend and provide informed consent.
Who cannot join
- Subject who is not a suitable candidate for a colonoscopy
- Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
- Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
- Patients with a disability to extend their tongue.
- Patients with tongue piercings.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Health
New York, New York, 10016
Westside GI
New York, New York, 10019
NewYork-Presbyterian / Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
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.
- Conditions
- Colorectal Neoplasms, Gastrointestinal Microbiome
- Being tested
- Gixam
- Keywords
- Artificial Intelligence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GixamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gixam followed by standard of care colonoscopy | Experimental | This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy Receives: Device: Gixam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Number of device related adverse events and serious adverse events
Measured: 1 day
Primary Efficacy Endpoint - Gixam's diagnostic accuracy
Gixam's diagnostic accuracy (sensitivity and specificity) of adenomatous colorectal polyps.
The Gixam's predictive value will be compared to the patient's colonoscopy + pathology (if any specimens are collected) findings as ground truth on a binary basis (YES/NO for adenomatous and sessile serrated polyps).
Measured: 14 days (till pathology report is received)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubaan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniella Bleistein, Study director, Jubaan Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305364
- Sponsor's protocol ID
- CL-1001
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
- ClinicalTrials.gov ID
- NCT06305364
- Acronym / sponsor ID
- CL-1001
- Conditions
- Colorectal Neoplasms, Gastrointestinal Microbiome
- Keywords
- Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Jubaan Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gixam followed by standard of care colonoscopy | Experimental | Device: GixamThis is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females
- Age: 18-75 years, inclusive
- Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:
- Able to comprehend and provide informed consent.
Key exclusion criteria (5 listed)
- Subject who is not a suitable candidate for a colonoscopy
- Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
- Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
- Patients with a disability to extend their tongue.
- Patients with tongue piercings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GixamParticipants 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. | Device | Gixam followed by standard of care colonoscopy |
Primary outcome
Primary Safety Endpoint - Number of device related adverse events and serious adverse events
Time frame: 1 day
Primary Efficacy Endpoint - Gixam's diagnostic accuracy
Time frame: 14 days (till pathology report is received)
Gixam's diagnostic accuracy (sensitivity and specificity) of adenomatous colorectal polyps. The Gixam's predictive value will be compared to the patient's colonoscopy + pathology (if any specimens are collected) findings as ground truth on a binary basis (YES/NO for adenomatous and sessile serrated polyps).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Jubaan's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniella Bleistein study director
Jubaan Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gixam in people with Colorectal Neoplasms and Gastrointestinal Microbiome, run by Jubaan Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - Number of device related adverse events and serious adverse events (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.