Open SurgeryPRIMENCT06628219
A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis
A study testing Symani Surgical System in people with Open Surgery and Lymphedema, run by MMI (Medical Microinstruments, Inc.).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Surgery, Lymphedema, Free Tissue Transfer
- What is being tested?
- Symani Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, according to the local law
- Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
- Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphedema surgery
- Investigator considers candidate acceptable for free flap transfer surgery and/or lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU
- For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)
- For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):
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- Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other
- Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units
- Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening
- Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration
- Patient must be diagnosed with Lymphedema
- Patient must have a body mass index (BMI) of ≤ 35
- In the opinion of the investigator, the patient has at least one identifiable indication for prophylactic lymphatic surgery.
- Patient must have a body mass index (BMI) of ≤ 35
Who cannot join
- Patients who are not capable and/or unwilling to provide informed consent
- Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.
- Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
- Patients with implanted pacemaker
- Planned vein graft (either venous or arterial)
- Previously documented history of chronic kidney disease (eGFR ≤ 30)
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- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator
- Patients with buried flaps
- Multiple flaps planned for the procedure
- Patients with venous edema (arising from increased capillary filtration)
- Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
- Current infection in the affected area of lymphedema
- Current evidence of malignancy
- Known iodine sensitivity
- Patient's lymphatic disease is due to lipedema
- Patients with bilateral lymphedema or lymphedema in multiple anatomical locations
- Patients for whom prophylactic surgery on more than one limb is planned
- Known iodine sensitivity
- Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator
- Patients diagnosed with lymphedema
- Patients who have received prior radiation therapy to the affected limb where the investigator believes the amount or extent of radiation could compromise the success of prophylactic lymphatic surgery
- Intraoperative Exclusion Criteria:
- Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest
- The patient does not have at least two robotic sutures attempted during the index procedure
About this study
Official title: A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis: Expanding Access to Care in Free Tissue Transfer Surgery and Lymphatic Surgery
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:
Read more
- 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.
- Conditions
- Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery
- Being tested
- Symani Surgical System
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symani Surgical SystemDevice
The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
| Study group | Role | What they receive |
|---|---|---|
| Free Tissue Transfer, Therapeutic Lymphatic Surgery, Prophylactic Lymphatic Surgery Participants | Experimental | Not described Receives: Device: Symani Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success, defined as intraoperative anastomosis patency.
Clinical Success is defined as intraoperative anastomosis patency. Intraoperative anastomosis patency will be measured for each robotic anastomosis (anastomosis contains at least two robotically placed sutures) per standard of care and will be evaluated prior to closure of the procedure site during the index procedure.
Measured: 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).
Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.
Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. All device-related serious adverse events will be descriptively summarized.
Measured: The duration of the participants' index procedure hospitalization (typically lasting under two weeks).
Secondary outcomes (3)
Freedom from a reoperation to revise a robotic anastomosis prior to discharge
Freedom from returning to the operating room for surgical revisions to an anastomosis that was deemed robotic (anastomosis contains at least two robotically placed sutures) in the index procedure. This endpoint will be evaluated at discharge for each participant.
Measured: The duration of the participants' index procedure hospitalization (typically lasting under two weeks).
Rate of intra-operative approach changes from robotic to manual
An intra-operative approach change is defined as a conversion from a robotic anastomosis approach to a manual anastomosis approach. This endpoint will be evaluated upon completion of the index procedure.
Measured: 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).
Technical success
Technical success is defined as freedom from device malfunction resulting in unplanned conventional suturing. Device malfunctions and the associated outcome will be collected. This endpoint will be evaluated upon completion of the index procedure.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2030 (estimated)
Why it stopped: Study replaced by post-approval requirement study NCT06725030
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628219
- Sponsor's protocol ID
- CDC-00134
- Acronym
- PRIME
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes