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RECRUITING
NCT06866197
NA

CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System

Sponsor: MMI (Medical Microinstruments, Inc.)

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System: A Novel Approach to the Next Frontier of Microsurgery and Expanding Access to Care in Free Tissue Transfer and Lymphatic Surgery

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-01-20

Completion Date

2029-01-20

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DEVICE

Symani Surgical System

The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.

Locations (1)

Saint Vincent's Hospital Melbourne

Melbourne, Victoria, Australia