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临床试验

A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

NCT:NCT06628219 · WITHDRAWN

NCT编号NCT06628219
状态WITHDRAWN
开始日期2025-02-01
完成时间2030-02-01
SponsorMMI (Medical Microinstruments, Inc.) (INDUSTRY)
First posted
Last updated

简要摘要

The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: * Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. * Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. * Participants will be asked to comply with the follow-up visits as outlined in the protocol.

官方来源

在 ClinicalTrials.gov 上查看 →

数据来自 ClinicalTrials.gov API。有关最新状态,请参阅官方记录。

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