Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani

Sponsor
MMI (Medical Microinstruments, Inc.)
Study ID
NCT07311876
Status
Recruiting
Apply to this trial

Conditions

  • External Lymphedema
  • Internal Lymphedema
  • Lymphedema
  • Lymphedema of Face
  • Lymphedema of Neck

Eligibility Criteria

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

Interventions

  • Symani Surgical System — DEVICE
    Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.

Study Details

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.

Key Dates

First listed
Dec 31, 2025
Start date
Jun 19, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Head and Neck Lymphedema
    The patients selected for the CLEAR Study will be adults over 22 years of age with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck.

Primary Outcome Measure

Intraoperative anastomosis patency prior to closure. [ Time Frame: The duration of the participants' index procedure. ]

Central Contacts

Related Studies