Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.

Colon Cancer Screening Clinical Trial

Official title:

Enhancing Polyp Detection: A Randomized Controlled Trial Comparing Combined Computer-Aid Detection and Polyp-Detecting Colonoscope Attachment to Computer-Aid Detection Alone in Patients Undergoing Colonoscopy.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06116864
• Other study ID #: 2094805
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: April 15, 2025

Study information

• Verified date: October 2023
• Source: Marshall University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1766
• Est. completion date: April 15, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Patients scheduled for an outpatient screening or surveillance colonoscopy.

Exclusion Criteria:

• Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).

• Patients requiring deep ileal intubation.

• Patients with inflammatory bowel disease.

• Patients with radiotherapy-induced colitis or other severe colitis.

• Patients with colonic strictures.

• Patients with acute diverticulitis.

• Patients with large bowel obstruction.

• Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).

• Patients scheduled for assessment of a known colonic lesion.

• Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.

• Patients with a history of colon resection.

• Patients on continuous anti-thrombotic therapy

• Pregnancy.

• Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.

• Patients who are vulnerable or unable to consent

Related Conditions & MeSH terms

• Colon Cancer Screening
• Colon Cancer Surveillance
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital	Huntington	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Marshall University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	It is the percentage of patients who have at least one adenoma detected during the colonoscopy	18 months
Secondary	Polyp detection rate		18 months
Secondary	Number of cancerous lesions		18 months
Secondary	Differences in polyps histology between the groups		18 months
Secondary	Differences in polyps size		18 months
Secondary	Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)		18 months
Secondary	Cecal intubation rate		18 months
Secondary	Cecal intubation time		18 months
Secondary	Colonoscopy withdrawal time		18 months
Secondary	Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods)		18 months