Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056544) titled 'The role of laser interstitial coagulation in vacuum aspiration biopsy and resection of breast tumors' on Dec. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Federal State Budgetary Scientific Institution Petrovsky National Research Centre of Surgery

Condition: Condition - benign neoplasms of breast Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effectiveness of LIC in VAB for therapeutic purposes in patients with single and multiple breast tumors; to describe the criteria for the effectiveness and sufficiency of LIC in VAB with intraoperative navigation in real time. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Vacuum aspiration biopsy and laser interstitial coagulation hemostasis/ultrasound control of hemorrhagic complications Interventions/Control_2 - Vacuum aspiration biopsy and medicamentous combined with compression hemostasis/ultrasound control of hemorrhagic complications

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - the presence of indications for VAB for diagnostic and therapeutic-diagnostic purposes in accordance with the national clinical recommendations, taking into account the procedure and standards for providing medical care according to the disease profile Key exclusion criteria - cytologically/histologically confirmed malignant nature of breast neoplasms. Target Size - 172

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 07 Month 15 Day Date of IRB - 2024 Year 05 Month 15 Day Anticipated trial start date - 2023 Year 08 Month 15 Day Last follow-up date - 2024 Year 04 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064606

Disclaimer: Curated by HT Syndication.