Clinical Trial: Randomized Controlled Trial Comparing Colorectal Adenoma Detection Rates Using LCI Combined with AI in Colonoscopy with Endocuff Vision vs. Transparent Hood (Japan)

Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059880) titled 'Randomized Controlled Trial Comparing Colorectal Adenoma Detection Rates Using LCI Combined with AI in Colonoscopy with Endocuff Vision vs. Transparent Hood' on Feb. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Saitama Medical University

Condition: Condition - Patients with positive fecal occult blood tests, abdominal symptoms, or follow-up for colorectal polyps Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study examined the adenoma detection rate (ADR) when using linked color imaging (LCI) and artificial intelligence (AI) during colonoscopy in patients with positive fecal occult blood tests, abdominal symptoms, or follow-up for colorectal polyps. (AI) during colonoscopy, comparing the adenoma detection rate (ADR) when using Endocuff Vision or a transparent hood attached to the scope tip. This study aims to clarify the usefulness of Endocuff Vision. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - colonoscopy with an Endocuff Vision Interventions/Control_2 - colonoscopy with a transparent hood

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients undergoing colonoscopy after pre-procedural preparation 2. Age: 18 years or older 3. Gender: Not restricted 4. Positive fecal occult blood test, abdominal symptoms, or Surveillance for post-colonoscopic polypectomy 5. Patients who received verbal and written explanations of this study and provided written informed consent Key exclusion criteria - 1. Patients undergoing colonoscopy without prior bowel preparation 2. Patients with intestinal obstruction, stricture, fistula, post-colonic surgery, active inflammatory bowel disease, diverticulitis, active rectal bleeding, or where such conditions cannot be ruled out 3. Patients with alcoholism or drug dependence 4. Patients with severe hormonal disorders such as hyperthyroidism 5. Patients with severe cardiac, hepatic, renal dysfunction, or hematopoietic disorders 6. Patients with severe heart failure or respiratory failure 7. Pregnant women, lactating women, or patients who may be pregnant, or patients who wish to become pregnant during the study period. 8. Patients participating in other studies or clinical trials that may directly or indirectly influence the results of this study. 9. Patients suffering from life-threatening diseases. 10. Patients deemed unsuitable for inclusion by the principal investigator or sub-investigator.iratory failure (NYHA Class III or higher, Hughes-Jones Class IV or higher). Target Size - 780

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 25 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068481

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