The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol...

Area of Science:

• Gastroenterology and Endoscopy
• Colorectal Cancer Screening
• Medical Device Technology

Background:

• Colonoscopy is the standard for diagnosing bowel conditions and screening for colorectal cancer.
• Higher adenoma detection rates (ADR) correlate with reduced interval cancer incidence.
• Technological advancements aim to enhance ADR, with Endocuff Vision™ showing promise in pilot studies.

Purpose of the Study:

• To compare the adenoma detection rate (ADR) of Endocuff Vision™-assisted colonoscopy against standard colonoscopy.
• To assess the efficacy of Endocuff Vision™ across screening, surveillance, and diagnostic colonoscopy patient groups.
• To provide evidence-based guidance for the clinical adoption of Endocuff Vision™.

Main Methods:

• A prospective, multicenter, randomized controlled trial involving 1772 patients aged 18+.
• Patients were randomized to receive either Endocuff Vision™-assisted or standard colonoscopy.
• Exclusion criteria included contraindications to colonoscopy, bowel obstruction, cancer, and inflammatory conditions.

Main Results:

• This section is not detailed in the provided abstract.
• Further analysis of collected colonoscopy and polyp data, including histology, is pending.
• Patient comfort and experience data were also collected post-procedure.

Conclusions:

• This is the first trial to assess Endocuff Vision™'s ADR in diverse colonoscopy indications.
• The study findings will inform clinicians about the potential role of Endocuff Vision™ in routine practice.
• Results are anticipated to impact quality metrics and patient outcomes in colonoscopy.