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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:
Participants will receive treatment as standard of care and be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free Tissue Transfer Surgery |
| ||
| Lymphovenous Anastomosis Surgery |
|
| 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 |
|---|---|---|
| Freedom from device-related adverse events from the start of the index procedure through 30-days post index procedure as adjudicated by a Clinical Events Committee | 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. | From participants index procedure through 30-days post index procedure. |
| Intraoperative anastomosis patency at first attempt. | Intraoperative anastomosis patency will be measured for each robotic anastomosis per standard of care and will be evaluated after the first attempt of the anastomosis during the index procedure. | The duration of the participants index procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative anastomosis patency prior to closure. | Intraoperative anastomosis patency prior to closure 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 participants index procedure. |
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Pre Operative Inclusion Criteria:
Cohort Specific Pre- Operative Inclusion Criteria:
Free Tissue Transfer Surgery: N/A
Lymphovenous Anastomosis Surgery
Swelling of one limb that is not completely reversed by elevation or compression
Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
At least one of the following positive quantitative measurements:
Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines, for at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
Willingness to comply with recommended regimen of self-care, with consistent use of appropriately sized compression garments from screening through the entire study duration (through the 3-month follow-up visit).
Pre-Operative Exclusion Criteria:
Cohort Specific Pre-Operative Exclusion Criteria:
Free Tissue Transplant Surgery:
Lymphovenous Anastomosis Surgery:
Intra Operative Exclusion Criteria:
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The patients selected for the PRECISE Study will be adults with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | 8336646276 | 5 | clinical.ops@mmimicro.com |
| Name | Affiliation | Role |
|---|---|---|
| Bohdan Pomahac, MD | Yale New Haven Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Recruiting | Beverly Hills | California | 90048 | United States |
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| Anastomosis suturing time (including robotic time and manual time). |
Anastomosis suturing time of the index procedure will be collected for each participant and summarized. Robotic anastomosis time and manual anastomosis time will be recorded for each anastomosis. For each anastomosis within an operation, the total suture time (robotic plus manual) will be derived as total robotic anastomosis time plus total manual anastomosis time. |
| The duration of participants index procedure. |
| Number of robotic and manual stitches per anastomosis. | The number of robotic stitches placed and the number of manual stitches placed per anastomosis in the index procedure will be collected for each anastomosis and summarized. For each anastomosis within an operation, the total stitches placed (robotic plus manual) will be derived as total robotic stitches placed plus total manual stitches. | The duration of participants index procedure. |
| Procedure time. | Procedure time of the index procedure will be collected for each participant and summarized. The incision start time and closure end time will be recorded. The procedural time will be derived from incision time subtracted from closure time. | The duration of participants index procedure. |
| 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 throughout the index procedure. | The duration of participants index procedure. |
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06511 | United States |
|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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