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

Trial Summary

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 data supports the effectiveness of the Gixam treatment for colorectal cancer screening?

The research highlights that using technology like the GI Genius™ system, which is similar to the Gixam device, can improve the detection of adenomas (pre-cancerous growths) during colonoscopy. This suggests that Gixam may also enhance the effectiveness of colorectal cancer screening by increasing the adenoma detection rate. ^{1 2 3 4 5}

How does the Gixam device differ from other colorectal cancer screening treatments?

The Gixam device for colorectal cancer screening is unique because it likely involves an immunochemical method to detect both fecal hemoglobin and albumin, which may increase screening effectiveness compared to traditional stool-based tests that typically focus on hemoglobin alone. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Can technology increase adenoma detection rate? [2022]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Can Technology Improve the Quality of Colonoscopy? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Seeing better--Evidence based recommendations on optimizing colonoscopy adenoma detection rate. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

Panoramic colonoscopy in colorectal cancer screening - a randomized controlled trial. [2022]

7. Hungary pubmed.ncbi.nlm.nih.gov

[Production and examination of double antigen specific immunoserum for immunochemical detection of occult blood]. [2006]

8. United States 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. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Colon cancer screening in 2010: an up-date. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

A comparative study of fecal occult blood tests for early detection of gastrointestinal pathology. [2015]