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

Sponsor
MMI (Medical Microinstruments, Inc.)
Study ID
NCT06628219
Status
Not Yet Recruiting

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Conditions

  • Free Tissue Transfer
  • Lymphedema
  • Microsurgery
  • Open Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 4, 2024
Start date
Feb 1, 2025
Status verified
Dec 2024
Primary completion
Feb 1, 2026
Completion
Feb 1, 2030

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Free Tissue Transfer, Therapeutic Lymphatic Surgery, Prophylactic Lymphatic Surgery Participants

Primary Outcome Measure

Clinical Success, defined as intraoperative anastomosis patency. [ Time Frame: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours). ]

Central Contacts

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