Colorectal CancerNCT06688110
Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer
A study testing Gixam System in people with Colorectal Cancer and Colorectal Adenomatous Polyp, run by Jubaan Ltd. at 1 site in Netherlands.
Trial summary
This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenomatous Polyp, Colorectal Neoplasms
- What is being tested?
- Gixam System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2025to Apr 2026
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥50 - ≤80 years.
- Able to provide a signed informed consent.
- Underwent FIT screening within the past 6 months with a positive result.
- Scheduled for a FIT positive screening colonoscopy at investigational site.
Who cannot join
- Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.
- Personal history of CRC.
- Family history of CRC, 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),
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
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- 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, and/or IBD-undefined.
- Subjects with the disability to extend their tongue.
- Subjects with tongue piercing.
- Dental visit in the 7 days prior to the 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.
About this study
This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.
Read the detailed description
- Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.
- Following the informed consent process, subjects will undergo the Gixam test.
- A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
- Both the subject and the endoscopist will be blinded to the Gixam outcome
- All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.
- All resected and retrieved lesions will be sent separately for histopathological evaluation.
- Being tested
- Gixam System
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gixam SystemDevice
Also called Colonoscopy
Jubaan's Gixam System is designed to predict the likelihood of colorectal adenomas or SSL by using white light in the 400 to 720 nm range to capture ultra-high-definition images of the of the tongue and analyzing the spectral signature of the oral microbiome to predict the presence of colorectal adenomas or SSL with help of artificial intelligence (AI).
| Study group | Role | What they receive |
|---|---|---|
| Gixam followed by standard of care colonoscopy | Experimental | All enrolled participants will undergo the Gixam test followed by a standard of care colonoscopy Receives: Device: Gixam System |
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 premalignant neoplastic colorectal polyps (advanced premalignant neoplastic lesions/non-advanced premalignant neoplastic lesion) and CRC
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 posted14 Nov 2024
- Study startFeb 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Sequential
- Model description
- All enrolled subjects will undergo the Gixam test followed by a standard of care colonoscopy
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubaan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jubaan GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688110
- Sponsor's protocol ID
- CL-1004
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06688110
- Acronym / sponsor ID
- CL-1004
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Jubaan Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jubaan GmbH
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Nov 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, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.
Detailed description
- Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.
- Following the informed consent process, subjects will undergo the Gixam test.
- A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
- Both the subject and the endoscopist will be blinded to the Gixam outcome
- All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.
- All resected and retrieved lesions will be sent separately for histopathological evaluation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled subjects will undergo the Gixam test followed by a standard of care colonoscopy
| Arm | Type | Receives |
|---|---|---|
| Gixam followed by standard of care colonoscopy | Experimental | Device: Gixam SystemAll enrolled participants will undergo the Gixam test followed by a standard of care colonoscopy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged ≥50 - ≤80 years.
- Able to provide a signed informed consent.
- Underwent FIT screening within the past 6 months with a positive result.
- Scheduled for a FIT positive screening colonoscopy at investigational site.
Key exclusion criteria (13 listed)
- Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.
- Personal history of CRC.
- Family history of CRC, 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:
- Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined.
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 SystemAlso: ColonoscopyJubaan's Gixam System is designed to predict the likelihood of colorectal adenomas or SSL by using white light in the 400 to 720 nm range to capture ultra-high-definition images of the of the tongue and analyzing the spectral signature of the oral microbiome to predict the presence of colorectal adenomas or SSL with help of artificial intelligence (AI). | Device | Gixam followed by standard of care colonoscopy |
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 premalignant neoplastic colorectal polyps (advanced premalignant neoplastic lesions/non-advanced premalignant neoplastic lesion) and CRC
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.
- 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.
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 Colorectal Cancer and Colorectal Adenomatous Polyp, run by Jubaan Ltd. at 1 site in Netherlands.
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 13 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 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 Netherlands. 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?
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.