Clinical trial NCT06116864: Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colon Cancer Screening
Colon Cancer Surveillance
Keywords: Colon cancer screening
Colon cancer surveillance
Computer-Aided Detection of adenoma
Colonoscope attachment device
Endocuff
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 1766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 18 months
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 18 months
measure: Number of cancerous lesions
timeFrame: 18 months
measure: Differences in polyps histology between the groups
timeFrame: 18 months
measure: Differences in polyps size
timeFrame: 18 months
measure: Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)
timeFrame: 18 months
measure: Cecal intubation rate
timeFrame: 18 months
measure: Cecal intubation time
timeFrame: 18 months
measure: Colonoscopy withdrawal time
timeFrame: 18 months
measure: Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods)
timeFrame: 18 months
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital
state: West Virginia
Study officials:
affiliation: Marshall University Joan C. Edwards School of Medicine
name: Wesam Frandah, MD
role: PRINCIPAL_INVESTIGATOR
References: