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

NCT02369692 | Terminated

• 1 other identifier: HMP 021 Embolization
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• 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)

  The primary performance endpoint is device success defined as 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, then accurate delivery of therapy. The primary safety endpoint is the incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies through the study period.

  2 Days

• 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)

  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

  2 Days

Secondary Outcomes (1)

• Number of Participation with Adverse Events

  30 days

Interventions

Magellan Robotic 6 Fr Catheter DEVICE

The Hansen Medical Magellan™ Robotic Catheter 6 Fr (Magellan™)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansen Medical: lead

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, France

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brenda Cayme, RN, BSN

  Hansen Medical Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 24, 2015
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 1, 2018

Record last verified: 2015-09

Locations

FR (1)