Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System

Hansen Medical

Status: Terminated

Conditions: Peripheral Vascular Disease

Treatments: Device: Magellan Robotic 6 Fr Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT02369692

HMP 021 Embolization

Details and patient eligibility

About

The purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).

The data will be analyzed for medical education, societal presentation and/or publication by the investigator.

Full description

The primary objectives of this study are to evaluate the safety and clinical performance of the Magellan Robotic System with the 6 Fr catheter, Vascular Accessories 6 Fr and Microcatheter Driver in patients who are indicated for an embolization procedure or other endovascular procedure in the peripheral vasculature.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Able and willing to provide written informed consent
• Eligible for an embolization procedure or other endovascular procedure in the peripheral vasculature
• Not participating in an investigational study involving the peripheral vasculature

Exclusion criteria

• Vasculature cannot accommodate the Magellan Robotic Catheter or required accessories
• The required delivery of therapeutic device(s) "through" the Magellan Robotic Catheter in which the diameter for the therapeutic device(s) is/are incompatible with the Magellan Robotic Catheter
• An endovascular approach to the treatment of peripheral vasculature disease is contraindicated
• Sepsis
• Major coagulation abnormalities
• Presence of significant co-morbid illness that contraindicates surgery or an interventional radiological procedure
• Unmanageable contrast agent hypersensitivity
• Patients who are prisoners
• Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or are deemed unreliable or unstable by the investigator or with a cognitive impairment
• Pregnant or breastfeeding