BridgeMD
New treatment option for Microsurgery
Official title CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
ClinicalTrials.gov ID: NCT06866197
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphatic surgery Investigator considers...
- For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for...
- For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of...
You likely can't join if
- 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...
- 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)
See the full eligibility criteria
Who can 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...
- Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphatic surgery Investigator considers candidate acceptable for free flap transfer surgery and/or lymphatic...
- 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):
- 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
- Maintain complete decongestive therapy (CDT), according to International Society of Lymphology (ISL) guidelines, for a minimum duration of four (4) 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 for Prophylactic Lymphatic Patients:
- The patient has at least one identifiable risk factor for developing lymphedema of the extremities
- Patient with a body mass index (BMI) of ≤ 35
What rules you out
- 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...
- 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)
- 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 Exclusion Criteria for Free Tissue Transfer Patients:
- Patients with buried flaps
- Multiple flaps planned for the procedure Exclusion Criteria for Therapeutic Lymphatic Patients:
- 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 Exclusion Criteria for Prophylactic Lymphatic Participants:
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.