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

NCT06116864 | Unknown FDA Device

• 1 other identifier: 2094805
• Study Type: interventional
• Target: 1,766
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer Screening; Colon Cancer Surveillance

Keywords

Colon cancer screening; Colon cancer surveillance; Computer-Aided Detection of adenoma; Colonoscope attachment device; Endocuff

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  It is the percentage of patients who have at least one adenoma detected during the colonoscopy

  18 months

Secondary Outcomes (9)

• Polyp detection rate

  18 months

• Number of cancerous lesions

  18 months

• Differences in polyps histology between the groups

  18 months

• Differences in polyps size

  18 months

• Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)

  18 months

Study Arms (2)

Endocuff + GI Genius

EXPERIMENTAL

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

Device: Endocuff and GI Genius

GI Genius

ACTIVE COMPARATOR

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

Device: GI Genius

Interventions

Endocuff and GI Genius DEVICE

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

Endocuff + GI Genius

GI Genius DEVICE

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

GI Genius

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Patients scheduled for an outpatient screening or surveillance colonoscopy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marshall University: lead

Study Sites (1)

Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Study Officials

• Wesam Frandah, MD

  Marshall University Joan C. Edwards School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: October 23, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)