Colorectal AdenomaPhase 2NCT06612281
Evaluation of Gixam's Performance in a FIT Negative Population
A Phase 2 study testing colorectal cancer (CRC) screening, colorectal cancer screening and Colonoscopy after bowel cleansing in people with Colorectal Adenoma and Colorectal Cancer (CRC), run by Jubaan Ltd. at 1 site in United States.
Trial summary
In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colorectal Adenoma, Colorectal Cancer (CRC), Colorectal Cancer (CRC) Screening
- What is being tested?
- colorectal cancer (CRC) screening, colorectal cancer screening and Colonoscopy after bowel cleansing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 30 Apr 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 45-85 years.
- Able to provide a signed informed consent.
- Scheduled for a screening colonoscopy at the investigation site.
Who cannot join
- Undergoing diagnostic colonoscopy for investigation of symptoms.
- Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
- History of colorectal cancer.
- Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
- Subject has a diagnosis or medical / family history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as \"FAP\", including attenuated FAP and Gardner\'s syndrome),
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- Hereditary non-polyposis CRC syndrome (also referred to as \"HNPCC\" or \"Lynch Syndrome\"),
- Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot\'s (or Crail\'s) Syndrome, Cowden\'s Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
- Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn\'s disease.
- Subjects with a disability to extend their tongue.
- Subjects with tongue piercing.
- Dental visit in the past 7 days prior to Gixam test.
- Intake of pro-biotics over the past 3 months pre-Gixam test.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Oregon Clinic Gastroenterology-East
Portland, Oregon, 97220
Diane Snelson, 503-963-2782, dsnelson@orclinic.com
About this study
In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.
The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.
The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.
- Being tested
- colorectal cancer (CRC) screening, colorectal cancer screening, Colonoscopy after bowel cleansing
- Keywords
- Microbiome, Spectral signature, 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.
colorectal cancer (CRC) screeningDevice
Gixam test
colorectal cancer screeningDiagnostic test
Fecal Immunochemistry Test (FIT)
Colonoscopy after bowel cleansingProcedure or surgery
Standard of care optical colonoscopy for colorectal cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy Receives: Device: colorectal cancer (CRC) screening; Diagnostic Test: colorectal cancer screening; Procedure: Colonoscopy after bowel cleansing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - number of device related adverse events and serious adverse events
Number of device related adverse events and serious adverse events
Measured: Through study completion, up to 30 days
Efficacy - Gixam's sensitivity and specificity
Gixam's sensitivity and specificity to predict the presence of colorectal adenoma or sessile serrated lesions (advances and non-advanced) / CRC in a FIT negative population.
Measured: Through study completion, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Nov 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies 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 2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects enrolled will undergo the same study procedures and assessments in the following order: FIT, Gixam, and colonoscopy. Gixam is an investigational medical device determined by the FDA to be a nonsignificant risk device. Colonoscopy is the ground-truth (Gixam outcome is compared to colonoscopy findings). Gixam performance will be evaluated and reported per FIT outcome (the primary efficacy endpoint is sensitivity and specificity in a FIT negative population).
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubaan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612281
- Sponsor's protocol ID
- CL-1015
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gixam's Performance in a FIT Negative Population
- ClinicalTrials.gov ID
- NCT06612281
- Acronym / sponsor ID
- CL-1015
- Keywords
- Microbiome, Spectral signature, Artificial intelligence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jubaan Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 25 Sep 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.
In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.
The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.
The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects enrolled will undergo the same study procedures and assessments in the following order: FIT, Gixam, and colonoscopy. Gixam is an investigational medical device determined by the FDA to be a nonsignificant risk device. Colonoscopy is the ground-truth (Gixam outcome is compared to colonoscopy findings). Gixam performance will be evaluated and reported per FIT outcome (the primary efficacy endpoint is sensitivity and specificity in a FIT negative population).
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: colorectal cancer (CRC) screening, Diagnostic Test: colorectal cancer screening, Procedure: Colonoscopy after bowel cleansingAll participants will undergo the same study procedures: FIT, Gixam, and colonoscopy |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 45-85 years.
- Able to provide a signed informed consent.
- Scheduled for a screening colonoscopy at the investigation site.
Key exclusion criteria (14 listed)
- Undergoing diagnostic colonoscopy for investigation of symptoms.
- Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
- History of colorectal cancer.
- Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
- Subject has a diagnosis or medical / family history of any of the following conditions, including:
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 |
|---|---|---|
| colorectal cancer (CRC) screeningGixam test | Device | Single arm |
| colorectal cancer screeningFecal Immunochemistry Test (FIT) | Diagnostic test | Single arm |
| Colonoscopy after bowel cleansingStandard of care optical colonoscopy for colorectal cancer screening | Procedure or surgery | Single arm |
Primary outcome
Safety - number of device related adverse events and serious adverse events
Time frame: Through study completion, up to 30 days
Number of device related adverse events and serious adverse events
Efficacy - Gixam's sensitivity and specificity
Time frame: Through study completion, up to 30 days
Gixam's sensitivity and specificity to predict the presence of colorectal adenoma or sessile serrated lesions (advances and non-advanced) / CRC in a FIT negative population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Related InfoLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing colorectal cancer (CRC) screening, colorectal cancer screening and Colonoscopy after bowel cleansing in people with Colorectal Adenoma and Colorectal Cancer (CRC), run by Jubaan Ltd. at 1 site 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniella Bleistein (+972549599353, daniella@jubaan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - number of device related adverse events and serious adverse events (time frame: Through study completion, up to 30 days). 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 14 Nov 2024.