Condition: Microsurgery · Lymphedema · Free Tissue Transfer · Sponsor: MMI (Medical Microinstruments, Inc.)
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.
This description comes directly from the study's public registry record.
Clinical Operations · 8336646276 · clinical.ops@mmimicro.com
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| Saint Vincent's Hospital Melbourne | Melbourne, Victoria, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06866197