Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058337) titled 'Use of an all-in-one sphincterotome with high rotation performance and freely bendable blade for Endoscopic Retrograde Cholangio-Pancreatography' on July 31.
Study Type:
Observational
Primary Sponsor:
Institute - Dokkyo Medical University School of Medicine
Condition:
Condition - Billiary tract desease
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study was to evaluate the clinical utility and optimal usage techniques of a newly developed all-in-one sphincterotome, released in May 2024, which offers superior rotational capability and a highly flexible tip, in ERCP-related procedures performed not only in patients with surgically altered anatomy but also in those with normal anatomy.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 28
years-old
=
Gender - Male and Female
Key inclusion criteria - Patientin which ERCP-related procedures were performed using all-in-one sphincterotome at Dokkyo Medical University Hospital between November 2023 and December 2024.
Key exclusion criteria - Cases in which consent to participate in the study was withdrawn after disclosure of information and cases in which the researcher determined that the patient was not excluded for this study.
Target Size - 140
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 11 Month 01 Day
Date of IRB - 2024 Year 03 Month 22 Day
Anticipated trial start date - 2023 Year 11 Month 01 Day
Last follow-up date - 2024 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066691
Disclaimer: Curated by HT Syndication.
