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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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free Tissue Transfer, Therapeutic Lymphatic Surgery, Prophylactic Lymphatic Surgery Participants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symani Surgical System | Device | The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 per standard of care and will be evaluated prior to closure of the procedure site during the index procedure. | 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 | Freedom from device-related serious adverse events prior to discharge from the index hospitalization. All device-related serious adverse events will be descriptively summarized. | The duration of the participants' index procedure hospitalization (typically lasting under two weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 in the index procedure. This endpoint will be evaluated at discharge for each participant. | The duration of the participants' index procedure hospitalization (typically lasting under two weeks) |
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Inclusion Criteria:
Inclusion Criteria for Therapeutic Lymphatic Patients:
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):
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
Inclusion Criteria for Prophylactic Lymphatic Patients:
Exclusion Criteria:
Exclusion Criteria for Free Tissue Transfer Patients:
Exclusion Criteria for Therapeutic Lymphatic Patients:
Exclusion Criteria for Prophylactic Lymphatic Participants:
Intraoperative Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | 8336646276 | 5 | clinical.ops@mmimicro.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Vincent's Hospital Melbourne | Recruiting | Melbourne | Victoria | 3065 | Australia |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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. | 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). |