Clinical trial NCT02369692: Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System
Official title: Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Vascular Disease
Lead sponsor: Hansen Medical
Sponsor class: INDUSTRY
First posted: 2015-02-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A subject must be a candidate for an embolization procedure or other endovascular procedure in the peripheral vasculature, meet all inclusion and no exclusion criteria, and be willing to comply with all protocol testing and follow-up.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Safety and Clinical Performance of the Magellan Robotic system with the 6 Fr Catheter. (incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies)
timeFrame: 2 Days
measure: Device success (Successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, the accurate delivery of Therapy)
timeFrame: 2 Days
Secondary outcomes:
measure: Number of Participation with Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: Hansen Medical Inc
name: Brenda Cayme, RN, BSN
role: STUDY_DIRECTOR
References: