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NCT06725030 · ClinicalTrials.gov registry record
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
A clinical trial of Lymphedema and Free Tissue Transfer, sponsored by MMI (Medical Microinstruments, Inc.).
- Recruiting
- Registry status
- 455
- Enrollment target
- 4
- Study locations
NCT06725030: Recruiting study of Lymphedema and Free Tissue Transfer, sponsored by MMI (Medical Microinstruments, Inc.).
NCT06725030 is a study of Lymphedema and Free Tissue Transfer that is actively recruiting participants, run by MMI (Medical Microinstruments, Inc.). The registered enrollment target is 455 participants, below the 9,286-participant average among 34 other Lymphedema trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06725030, a study of Lymphedema and Free Tissue Transfer, is actively recruiting participants, sponsored by MMI (Medical Microinstruments, Inc.).
- RECRUITING
- Registry status
- 455 participants
- Enrollment target
- 4
- Study locations
Study Summary
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. 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 lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.
Primary Outcome
All adverse events will be evaluated from the start of the index procedure through 30-days post index procedure. Adverse events will be reviewed by a Clinical Events Committee (CEC) to determine probable or causal relationships with the device. All device-related serious adverse events will be summarized descriptively.
Conditions Studied
Interventions
- DEVICE Symani Surgical System
Study Locations (4)
California
- Cedars Sinai Medical Center - Beverly Hills
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- Tampa General Hospital - Tampa
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2025-09-22 |
| Est. Completion | 2027-12-01 |
What NCT06725030 shows while recruiting
NCT06725030 is an observational study that tracks outcomes without assigning an intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 9,286-participant average among 34 other Lymphedema trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Lymphedema appearing as the primary indexed condition, and to 1 intervention - of which Symani Surgical System is the first listed.
NCT06725030 reports a single indexed study location in California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT06725030 about?
NCT06725030 is a clinical study titled "A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons". The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. *...
What is the current status of trial NCT06725030?
This trial is currently recruiting. The enrollment target is 455 participants. The study started on 2025-09-22. Estimated completion is 2027-12-01.
What conditions does trial NCT06725030 study?
This clinical trial studies the following conditions: Lymphedema, Free Tissue Transfer, Anastomosis, Surgical, Open Surgery, Microsurgery.
What interventions are being tested in trial NCT06725030?
The interventions under investigation include: Symani Surgical System (DEVICE).
Who is sponsoring clinical trial NCT06725030?
This trial is sponsored by MMI (Medical Microinstruments, Inc.), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06725030 being conducted?
This trial has 4 study locations across California, Connecticut, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06725030's enrollment target sits among peer trials
455 6th of 34 higher than 29 of 34 other Lymphedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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