IMPEDE and IMPEDE-FX Embolization Plug Registry (EMBO-PMS)

May 3, 2022 updated by: Shape Memory Medical, Inc.

Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs

EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • St George's Hospital (St George's University Hospitals NHS Foundation Trust)
        • Contact:
        • Principal Investigator:
          • Robert Morgan, MBChB
        • Sub-Investigator:
          • Ian Loftus, MBChB MD
        • Sub-Investigator:
          • Leto Mailli, MD PhD
        • Sub-Investigator:
          • Raj Das, MBBS
      • London, United Kingdom
        • Recruiting
        • St Mary's Hospital (Imperial College Healthcare NHS Trust)
        • Contact:
        • Principal Investigator:
          • Mohamad Hamady, MBChB

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult study participants considered candidates for a peripheral vascular embolization procedure

Description

Inclusion Criteria:

  • Study participant is ≥18 years of age
  • Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature

Exclusion Criteria:

  • Study participant has an inability to provide written informed consent
  • Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
  • Study participant is a prisoner or member of other vulnerable population

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Rate of freedom from serious adverse events
Time Frame: 30 days
Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
30 days
Efficacy - Rate of technical success (embolization of target vessel)
Time Frame: Immediately after the intervention
Technical success, defined as embolization of the target area after deployment of the study device
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Rate of recurrence of clinical symptoms, based on original complaint
Time Frame: 90 days
Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint
90 days
Efficacy - Rate of treated vessel occlusion
Time Frame: 90 days
Treated vessel occlusion, measured per study site standard of care for the original condition treated
90 days
Safety - Rate of freedom from serious adverse events
Time Frame: 90 days
Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shape Memory Medical, Inc.

Investigators

  • Study Chair: Kyriakos Lobotesis, MBBS, Charing Cross Hospital (Imperial College Healthcare NHS Trust)

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 Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CRD1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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