IMPEDE and IMPEDE-FX Embolization Plug Registry
Research type
Research Study
Full title
Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
IRAS ID
250759
Contact name
Robert Morgan
Contact email
Sponsor organisation
Shape Memory Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The objective of this study is to collect data on the routine clinical use of the IMPEDE Embolization Plug and IMPEDE-FX Embolization Plug. The IMPEDE and closely-related IMPEDE-FX embolization plugs are medical devices and are CE marked products. They are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. Embolization (stopping the blood flow) of blood vessels using medical devices delivered through a catheter is a commonly-used technique used to treat a wide range of conditions – aneurysms of the renal arteries, varicoceles, and targeted radiation therapy for the treatment of cancer are just a few examples.
The IMPEDE and IMPEDE-FX embolization plugs are based on shape memory polymer technology. This polymer is able to exist in two stable shapes. The polymer can be crimped to a state where is can be part of a device delivered through a narrow catheter. But once the polymer is deployed into a blood vessel, it self-expands to fill the vessel and block blood flow. The polymer has many properties that make it ideal for blocking blood vessels – a porous structure for rapid clot formation, high vessel conformability, and low radial force (and therefore low vessel trauma) are a few examples.
The IMPEDE and IMPEDE-FX embolization plugs may be used to treat many different condition and this study is designed to collect data on the routine clinical use of the devices. The study will enroll up to 50 participants, who are suffering from conditions that can be treated with trans-catheter embolization. The study will be conducted by physicians familiar with trans-catheter embolization, and the participants will undergo standard of care procedures for the treatment of their condition with the IMPEDE and/or IMPEDE-FX embolization plugs, per the instructions for use of the devices.REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0767
Date of REC Opinion
26 Apr 2019
REC opinion
Favourable Opinion