Gixam Device for Colorectal Cancer Screening

Overseen By Daniella Bleistein

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jubaan Ltd.

Disqualifiers: Colorectal cancer, Family history, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Gixam, which uses a special camera and artificial intelligence to predict precancerous polyps in the colon by analyzing images of the tongue. The goal is to determine how accurately Gixam detects these polyps compared to a standard colonoscopy. It targets individuals who have recently had a negative result on a stool test known as FIT and are planning a routine screening colonoscopy. Ideal candidates for this trial have no family history of colorectal cancer, no recent colonoscopy, and no history of bowel diseases like Crohn’s disease. This research aims to simplify early detection of potential issues and prevent colorectal cancer development. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage advancements in colorectal cancer prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have taken probiotics in the past 3 months before the Gixam test.

What prior data suggests that the Gixam device is safe for colorectal cancer screening?

Research shows that the Gixam device is undergoing tests to determine if it can predict early signs of colon cancer by analyzing tongue images. Although detailed information about side effects or safety issues is limited, the current trial phase provides some insights. This phase indicates that Gixam has passed basic safety tests and is now being evaluated for effectiveness and side effects in a larger group. This suggests general safety, but further research is needed to confirm its safety in a broader population. Researchers will closely monitor trial participants to ensure their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Gixam device is unique because it combines non-invasive screening with advanced technology to detect colorectal cancer. Unlike traditional methods like colonoscopy, which are invasive and require preparation, Gixam offers a more comfortable and accessible option through a device-based screening. Researchers are excited about its potential to improve early detection rates, making it easier for people to get screened regularly and catch cancer at an earlier, more treatable stage. Additionally, Gixam may provide more accurate results by integrating multiple types of tests, such as the FIT test, into one streamlined process.

What evidence suggests that the Gixam device is effective for colorectal cancer screening?

Research has shown that the Gixam device uses images of the tongue to predict the likelihood of early-stage growths, known as polyps, in the colon or rectum. These growths can develop into colorectal cancer if not removed. Early studies suggest that Gixam's AI technology can effectively identify individuals at risk of developing these polyps. This identification encourages them to undergo a colonoscopy, the only test that can detect and remove polyps. This method aims to catch potential issues early, reducing the risk of cancer. All participants in this trial will undergo the same study procedures: FIT, Gixam, and colonoscopy. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have tested negative on a Fecal Immunochemical Test (FIT) but still need to undergo colonoscopy screening for colorectal cancer. The study aims to include those who are due for standard care colonoscopy as part of their regular health check-up.

Inclusion Criteria

Able to provide a signed informed consent

I am between 45 and 85 years old.

I am scheduled for a colonoscopy at the study location.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gixam Device Evaluation

Participants undergo evaluation using the Gixam device to predict the presence of precancerous polyps

1 day

1 visit (in-person)

Colonoscopy

Participants undergo a standard care colonoscopy to compare with Gixam's predictions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gixam

Trial Overview The Gixam device, which uses images of the tongue and artificial intelligence to predict the presence of precancerous polyps in the colon or rectum, is being evaluated. Its accuracy will be compared with actual colonoscopy results.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 3 Interventions

All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy

Who Is Running the Clinical Trial?

Jubaan Ltd.

Lead Sponsor

Trials

3

Recruited

1,600+

Published Research Related to This Trial

AI-supported colonoscopies significantly improve adenoma detection rates (ADR) and polyp detection rates (PDR) compared to standard colonoscopy, with odds ratios of 1.51 and 1.89 respectively, based on a meta-analysis of 11 trials involving 6856 participants.

The use of AI did not lead to longer withdrawal times during colonoscopy, indicating that the integration of AI technology can enhance detection without compromising procedural efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of real-time computer-aided and quality control systems in colorectal adenoma and polyp detection during colonoscopies: a meta-analysis. Aslam, MF., Bano, S., Khalid, M., et al.[2023]

High-quality colonoscopy is essential for effectively reducing colon cancer incidence, and recent guidelines emphasize higher adenoma detection rates as a key quality metric.

Simple, low-cost interventions, such as better procedure techniques and split-dose bowel preparation, can significantly enhance the quality of colonoscopy, alongside emerging technologies that improve visualization and image quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Technology Improve the Quality of Colonoscopy? Thirumurthi, S., Ross, WA., Raju, GS.[2018]

Colonoscopy is the gold standard for colorectal cancer screening, and its effectiveness is significantly influenced by the adenoma detection rate (ADR), which measures how many patients are found to have adenomas during screening.

Improving ADR can be achieved through various techniques, such as better pre-colonoscopy preparation, using additional observers, and employing advanced endoscopic methods, all of which aim to enhance the visibility and detection of abnormalities in the colon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeing better--Evidence based recommendations on optimizing colonoscopy adenoma detection rate. Aranda-Hernández, J., Hwang, J., Kandel, G.[2022]

The COLO-DETECT trial will assess the effectiveness of the GI Genius™ computer-aided detection system in improving adenoma detection rates during colonoscopy, involving 1828 participants across various NHS sites in England.

This study is significant as it will be the first multi-centre randomized controlled trial to evaluate both the clinical and cost-effectiveness of GI Genius™ in routine colonoscopy practice, potentially enhancing colorectal cancer screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius™ artificial intelligence endoscopy module with standard colonoscopy. Seager, A., Sharp, L., Hampton, JS., et al.[2022]

A new immunochemical method was developed to simultaneously detect fecal hemoglobin and albumin, which enhances the effectiveness of colorectal cancer screening in individuals over 40 years old, tested on a group of 1196 participants.

The method demonstrated high analytical sensitivity (0.5 microg/ml for both proteins) and improved the safety and intensity of detection without compromising specificity, effectively doubling the number of tests that can be performed at the same cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Production and examination of double antigen specific immunoserum for immunochemical detection of occult blood]. Sz Németh, M., Ottó, S.[2006]

Colorectal cancer is highly prevalent, but early detection through screening for premalignant adenomatous polyps can significantly improve prognosis, especially in limited disease stages.

The article reviews various screening methods, including stool tests, radiologic tests, and endoscopy, and discusses their current use in population-based screening programs and the latest guidelines from major health organizations in North America and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colon cancer screening in 2010: an up-date. Weizman, AV., Nguyen, GC.[2015]

Colorectal cancer is a major health concern, being the third most common cancer globally and the second leading cause of cancer deaths in Europe and North America, highlighting the importance of effective screening methods like colonoscopy.

The adenoma detection rate is crucial for assessing the quality of colonoscopy, as low detection rates are linked to higher risks of colorectal cancer, indicating a need for improved detection technologies during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can technology increase adenoma detection rate? Ngu, WS., Rees, C.[2022]

The study involved 421 patients and compared standard frontal view colonoscopy (SFV) with 330° panoramic view colonoscopy (PVC), finding that PVC increased the detection of diverticula and polyps in certain areas, but did not significantly improve the overall adenoma detection rate (ADR).

While the median cecal intubation time was longer for PVC (311 seconds) compared to SFV (234 seconds), both techniques showed similar effectiveness in detecting advanced adenomas, indicating that PVC may enhance visualization but does not necessarily lead to better cancer screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panoramic colonoscopy in colorectal cancer screening - a randomized controlled trial. Bogacki, P., Gach, T., Krzak, J., et al.[2022]

Fecal occult blood testing is effective in reducing colorectal cancer incidence and mortality in average-risk adults over 50, based on evidence from multiple randomized trials.

While sigmoidoscopy and possibly colonoscopy also show effectiveness in reducing colon cancer rates, the best screening method remains unclear due to insufficient data on comparative effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for colorectal cancer in adults at average risk: a summary of the evidence for the U.S. Preventive Services Task Force. Pignone, M., Rich, M., Teutsch, SM., et al.[2022]

In a study of 120 patients, the combination of a monoclonal antibody guaiac test (Monohaem) with a highly sensitive guaiac test (Fecatwin S) showed the highest efficiency for detecting fecal occult blood at 93%, indicating its potential for early detection of gastrointestinal bleeding.

The study suggests that using both a specific test for human hemoglobin and a sensitive guaiac test could improve mass screening strategies for conditions like colorectal cancer, highlighting the importance of combining different testing methods for better diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of fecal occult blood tests for early detection of gastrointestinal pathology. Stelling, HP., Maimon, HN., Smith, RA., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06688110

Evaluation of Gixam's Efficacy Predicting Pre-cancerous ... 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- ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/555820

Evaluation of Gixam's Efficacy Predicting Pre-cancerous ... This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06612281

Evaluation of Gixam's Performance in a FIT Negative ... 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, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10093633/

Effectiveness of Colorectal Cancer (CRC) Screening on All ... Based on RCTs and model studies, biennial FIT/gFOBT, single and 5-yearly FS, and 10-yearly colonoscopy screening significantly reduces CRC-specific mortality.

5. mdpi.com mdpi.com/2072-6694/17/21/3537

Artificial Intelligence in Oncology: A 10-Year ClinicalTrials. ... Colorectal, Detection (Colonoscopy), Gixam device uses AI-analyzed tongue images to predict colorectal adenomas. NCT06888089 (2023, n = 20,707), Multiple or ...

6. withpower.com withpower.com/trial/phase-2-colorectal-cancer-crc-screening-8-2024-93de9

Gixam Device for Colorectal Cancer Screening This Phase 2 medical study run by Jubaan Ltd. is evaluating whether Gixam will have tolerable side effects & efficacy for patients with Colorectal Cancer, ...

7. geneoscopy.com geneoscopy.com/geneoscopys-preventive-screening-test-for-colorectal-cancer-and-precancerous-adenomas-earns-fda-breakthrough-device-designation/

Geneoscopy's Preventive Screening Test for Colorectal ... Geneoscopy's preliminary data indicate that its screening test could provide a more effective method for early detection of advanced adenomas.