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New treatment option for Lymphedema
Official title Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
ClinicalTrials.gov ID: NCT07311876
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- At least 22 years of age
- Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
- Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided...
- Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of...
- Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
You likely can't join if
- Patient who is incapable and/or unwilling to provide informed consent
- Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
- Active systemic infection under treatment with intravenous antibiotics
- Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other...
- Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
- Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)
See the full eligibility criteria
- At least 22 years of age
- Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
- Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the...
- Patient has 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
- Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
- Patient has undergone lymphatic mapping of the head and neck and functional lymphatic structures for reconstruction have been identified
- Investigator deems the candidate acceptable for lymphatic reconstruction with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
- Willingness to comply with recommended regimen of self-care, with consistent use of manual lymph drainage and/or appropriately sized compression garments from screening through the entire study duration (through the...
- Patient who is incapable and/or unwilling to provide informed consent
- Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
- Active systemic infection under treatment with intravenous antibiotics
- Clinically significant cardiovascular, digestive, respiratory, endocrine, 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
- Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)
- A history of malignancy or cancer treatment within the past 6 months (tumor control)
- Patient with unsatisfactory manual lymphatic drainage and/or compression garments for at least six months
- Patient with prior lymphatic reconstruction in the targeted head \& neck area
- Patient's lymphatic disease is due to lipedema
- Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema (e.g., thrombosis in the external or internal jugular vein)
- Current infection in the head \& neck area in which lymphedema is present
- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- Patient is ineligible to participate for other reasons in the judgement of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Kiel, Germany
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, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kiel, Germany. 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.