RECRUITING

A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

Conditions

Open Surgery Lymphedema Free Tissue Transfer Microsurgery Anastomosis, Surgical

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. 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 lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

Official Title

PRECISE: A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

Quick Facts

Study Start:2025-09-01

Study Completion:2027-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06725030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 22 years of age 2. 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 study, its requirements, and the robotic assisted procedure 3. Patient has 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 4. Investigator deems the candidate acceptable for free flap transfer surgery and/or lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)	1. Patients who are incapable and/or unwilling to provide informed consent 2. Active systemic infection under treatment with intravenous antibiotics 3. 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 ability to comply with the protocol per the investigators discretion 4. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease 5. Patients with implanted pacemaker 6. Planned vein graft 7. Currently receiving chemotherapy or radiation therapy 8. History of chronic kidney disease 9. History of chronic liver disease 10. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes 11. Patients belonging to vulnerable populations, such as pregnant women, or ineligible to participate for other reasons in the judgement of the investigator

Inclusion Criteria

Exclusion Criteria

1. At least 22 years of age
2. 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 study, its requirements, and the robotic assisted procedure
3. Patient has 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
4. Investigator deems the candidate acceptable for free flap transfer surgery and/or lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)

1. Patients who are incapable and/or unwilling to provide informed consent
2. Active systemic infection under treatment with intravenous antibiotics
3. 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 ability to comply with the protocol per the investigators discretion
4. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
5. Patients with implanted pacemaker
6. Planned vein graft
7. Currently receiving chemotherapy or radiation therapy
8. History of chronic kidney disease
9. History of chronic liver disease
10. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
11. Patients belonging to vulnerable populations, such as pregnant women, or ineligible to participate for other reasons in the judgement of the investigator

Contacts and Locations

Study Contact

Clinical Operations

CONTACT

8336646276

clinical.ops@mmimicro.com

Study Locations (Sites)

Cedars Sinai Medical Center

Beverly Hills, California, 90048

United States

Collaborators and Investigators

Sponsor: MMI (Medical Microinstruments, Inc.)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01

Study Completion Date2027-12-01

Study Record Updates

Study Start Date2025-09-01

Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

Open Surgery
Lymphedema
Free Tissue Transfer
Microsurgery
Anastomosis, Surgical