Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059058) titled 'Efficacy of Linked Color Imaging-Assisted Colonoscopy with Artificial Intelligence for Adenoma Detection Rate without Antispasmodic Use: A Multicenter Randomized Controlled Trial' on Sept. 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Nippon Medical School Graduate School of Medicine

Condition: Condition - Colon polyp Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether observation with CADe under LCI is effective in improving the rate of adenoma detection under poor visual field conditions with intestinal peristalsis by comparing a group of patients without antispasmodic medication who were observed with CADe under LCI observation with a group who were observed with WLI alone. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - LCI/CADe group: observation from the cecum to the rectum is performed using LCI mode with CADe (CAD EYE: Fujifilm Medical Corporation) assistance. Interventions/Control_2 - WLI group: observation from cecum to rectum with normal light.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. persons aged 20 years and over who undergo a planned colonoscopy. 2. persons undergoing colonoscopy with the purpose of examination as "asymptomatic patients, including second-line screening (screening)", "patients with a history of polypectomy and for follow-up purposes (surveillance)" or 'symptomatic scrutiny' 3. patients who do not wish to use or are clinically unable to use the antispasmodic drug butylscopolamine bromide (cardiac disease, history of angle closure glaucoma or glaucoma, benign prostatic hyperplasia, history of hyperthyroidism, drug allergy, etc.) 4. those who do not wish to use or are clinically unable to use the antispasmodic drug glucagon (e.g. history of diabetes, blood glucose and HbA1c not measured by blood sampling within 1 month of the examination and diabetes cannot be ruled out) 5. persons for whom the study has been explained in writing and written consent has been obtained. Key exclusion criteria - 1. those with a history of inflammatory bowel disease 2. persons with active gastrointestinal bleeding 3. who have undergone bowel resection 4. those with a history of familial adenomatous polyposis 5. persons with previously known severe intestinal adhesions 6. any other person who is judged by the principal investigator or principal study investigator to be unsuitable to participate in the study. Target Size - 210

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 14 Day Date of IRB - 2025 Year 08 Month 28 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066531

Disclaimer: Curated by HT Syndication.