Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062294) titled 'A Single-Center Prospective Exploratory Study Evaluating the Utility of a Novel Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition of Upper Gastrointestinal Subepithelial Lesions Measuring 10-19 mm' on July 21.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Department of Gastroenterology, Kitasato University School of Medicine
Condition:
Condition - Gastrointestinal subepithelial lesion
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the utility of endoscopic ultrasound-guided tissue acquisition (EUS-TA) using a novel biopsy needle (SecureFlex) for 10-19 mm upper gastrointestinal subepithelial lesions.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Endoscopic ultrasound-guided tissue acquisition (EUS-TA) using a novel biopsy needle (SecureFlex)
Eligibility:
Age-lower limit - 18
years-old
=18 years who have provided written informed consent to participate in this study.
Key exclusion criteria - 1) Patients with coagulopathy or a bleeding tendency.
2) Patients with severe psychiatric disorders.
3) Pregnant patients.
4) Patients with a medical condition that makes sedation difficult or inappropriate.
Target Size - 10
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 25 Day
Date of IRB - 2026 Year 07 Month 21 Day
Anticipated trial start date - 2026 Year 07 Month 21 Day
Last follow-up date - 2028 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071052
Disclaimer: Curated by HT Syndication.
