Endocuff + GI Genius for Colon Cancer Detection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marshall University

Must not be taking: Anti-thrombotics

Disqualifiers: Inflammatory bowel disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1766 Participants Needed

Trial Summary

What is the purpose of this trial?

Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.

Research Team

Wesam Frandah, MD

Principal Investigator

Marshall University Joan C. Edwards School of Medicine

Eligibility Criteria

This trial is for adults over 18 who are due for a routine outpatient colonoscopy to screen or monitor for colorectal cancer. It's not suitable for pregnant individuals, those with severe colitis, bowel obstructions, history of colon surgery, hereditary polyposis syndrome, untreated colon cancer or on continuous anti-thrombotic therapy.

Inclusion Criteria

I am older than 18 years.

I am scheduled for a routine colonoscopy check.

Exclusion Criteria

Pregnancy

You need a special procedure called deep ileal intubation.

I have a narrowing in my colon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonoscopy procedures using either the Endocuff with CADe or CADe alone for colorectal cancer screening and surveillance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adenoma detection rate and safety after the colonoscopy procedure

18 months

Treatment Details

Interventions

• CADe
• Endocuff

Trial Overview The study tests if adding an Endocuff device to the GI Genius computer-aided detection system improves polyp detection during a colonoscopy compared to using GI Genius alone. The goal is to see if this combination leads to better screening outcomes.

Participant Groups

Group I: Endocuff + GI Genius Experimental Treatment 1 Intervention

Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Group II: GI Genius Active Control 1 Intervention

GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Who Is Running the Clinical Trial?

Marshall University

Lead Sponsor

Trials

21

Recruited

3,900+