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

Sponsor
MMI (Medical Microinstruments, Inc.)
Study ID
NCT06866197
Status
Recruiting
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Conditions

  • Free Tissue Transfer
  • Lymphedema
  • Microsurgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
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
Mar 10, 2025
Start date
Jan 20, 2026
Status verified
Mar 2026
Primary completion
Jan 20, 2028
Completion
Jan 20, 2029

Study Design

Enrollment
180 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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