CRC ScreeningNCT07894081
Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia
A study testing Gixam System in people with CRC Screening, run by Jubaan Ltd. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy. Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- CRC Screening
- What is being tested?
- Gixam System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 31 Mar 2027
- Phase
- Interventional
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥45 - ≤84 years.
- Able to provide a signed informed consent.
- Considered by a physician or healthcare provider as being of 'average risk' for CRC.
- Scheduled for a screening colonoscopy at investigation site.
Who cannot join
- Undergoing 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.
- Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
- Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
- 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.
Show all 19Show fewer
- Participant 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)
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- Other hereditary cancer syndromes including but 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.
- Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
- Participants with a disability to extend their tongue.
- Participants with tongue tremor.
- Participants with tongue piercing.
- Participants that had a dental visit in the 7 days prior to the Gixam test.
- Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
- Participants that have taken probiotics in the 14 days prior to the Gixam test.
- Participant is pregnant.
- Participant 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
Orlando Gastroenterology, PA
Orlando, Florida, 32835
About this study
The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy. The main questions it aims to answer are:
- Does Gixam give the same result when the test is repeated on the same day, with the same device and the same staff member (repeatability)?
- Does Gixam give the same result when the test is done on different days, with different devices and different staff members (reproducibility)?
Read more
Participants will:
- Answer questions about their health, medicines, diet, alcohol and tobacco use, and oral care habits
- Have the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14
- On Days 7 and 14, report when they last ate, drank or smoked, and whether they brushed, scraped their tongue or used mouthwash
- Then join the main Gixam study (CL-1009) for a FIT stool test and their planned colonoscopy
- Conditions
- CRC Screening
- Being tested
- Gixam System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gixam SystemDevice
Repeated Gixam tests, 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | All study participants will undergo the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14 Receives: Device: Gixam System |
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: From enrollment to the end of the study at 14 days after
Gixam repeatability - precision within-system-within-operator of all Runs
Success criteria
- NPA lower limit of the two-sided 95% confidence interval > 85%
- PPA lower limit of the two-sided 95% confidence interval > 80%
Measured: Through study completion, an average of 14 days
Gixam reproducibility - precision between-system-between-operator of all Systems/Operators
Success criteria
- NPA lower limit of the two-sided 95% confidence interval > 80%
- PPA lower limit of the two-sided 95% confidence interval > 75%
Measured: Through study completion, an average of 14 days
Secondary outcomes (1)
Gixam reported continuous probability score
This endpoint will be used to calculate variability across the repeated assessments (standard deviations and coefficients of variation).
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC ScreeningStudies 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
- 120 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
- NCT07894081
- Sponsor's protocol ID
- CL-1022
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT07894081
- Acronym / sponsor ID
- CL-1022
- Conditions
- CRC Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jubaan Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy. The main questions it aims to answer are:
- Does Gixam give the same result when the test is repeated on the same day, with the same device and the same staff member (repeatability)?
- Does Gixam give the same result when the test is done on different days, with different devices and different staff members (reproducibility)?
Participants will:
- Answer questions about their health, medicines, diet, alcohol and tobacco use, and oral care habits
- Have the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14
- On Days 7 and 14, report when they last ate, drank or smoked, and whether they brushed, scraped their tongue or used mouthwash
- Then join the main Gixam study (CL-1009) for a FIT stool test and their planned colonoscopy
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Gixam SystemAll study participants will undergo the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14 |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged ≥45 - ≤84 years.
- Able to provide a signed informed consent.
- Considered by a physician or healthcare provider as being of 'average risk' for CRC.
- Scheduled for a screening colonoscopy at investigation site.
Key exclusion criteria (19 listed)
- Undergoing 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.
- Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
- Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
- History of colorectal cancer.
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 |
|---|---|---|
| Gixam SystemRepeated Gixam tests, 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14 | Device | Intervention arm |
Primary outcome
Primary Safety Endpoint
Time frame: From enrollment to the end of the study at 14 days after
Number of device-related adverse events and serious adverse events.
Gixam repeatability - precision within-system-within-operator of all Runs
Time frame: Through study completion, an average of 14 days
Success criteria 1. NPA lower limit of the two-sided 95% confidence interval > 85% 2. PPA lower limit of the two-sided 95% confidence interval > 80%
Gixam reproducibility - precision between-system-between-operator of all Systems/Operators
Time frame: Through study completion, an average of 14 days
Success criteria 1. NPA lower limit of the two-sided 95% confidence interval > 80% 2. PPA lower limit of the two-sided 95% confidence interval > 75%
1 secondary outcome
Gixam reported continuous probability score
Time frame: Through study completion, an average of 14 days
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 26 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gixam System in people with CRC Screening, 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 4 inclusion and 19 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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.
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?
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 (time frame: From enrollment to the end of the study at 14 days after). The study lists 3 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 26 Oct 2026.