Registry for IMPEDE and IMPEDE-FX Embolization Plug Systems
Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
Shape Memory Medical, Inc. · NCT04044443
This study is collecting information on how safe and effective the IMPEDE and IMPEDE-FX Embolization Plug Systems are for patients getting treatment for blood vessel issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shape Memory Medical, Inc. (industry) |
| Locations | 10 sites (Dresden and 9 other locations) |
| Trial ID | NCT04044443 on ClinicalTrials.gov |
What this trial studies
This observational registry study collects data on the use of IMPEDE and IMPEDE-FX Embolization Plug Systems in patients undergoing arterial or venous embolization of the peripheral vasculature. It aims to evaluate the safety and effectiveness of these devices in a multicenter setting. Participants will be monitored for outcomes related to their embolization procedures, contributing to a better understanding of these medical devices in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are suitable for arterial or venous embolization.
Not a fit: Patients who cannot provide informed consent or are part of vulnerable populations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of embolization procedures for patients with peripheral vascular conditions.
How similar studies have performed: Other studies involving embolization devices have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dresden and 9 other locations
- Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden — Dresden, Germany (NOT_YET_RECRUITING)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (RECRUITING)
- Universitätsklinikum Schleswig-Holstein (Campus Kiel) — Kiel, Germany (RECRUITING)
- UNIVERSITÄTSKLINIKUM LEIPZIG AöR — Leipzig, Germany (RECRUITING)
- Klinikum München rechts der Isar — München, Germany (RECRUITING)
- Klinikum Nürnberg — Nürnberg, Germany (RECRUITING)
- Klinikum StuttGart — Stuttgart, Germany (RECRUITING)
- Uniklinikum Würzburg — Würzburg, Germany (RECRUITING)
- St George's Hospital (St George's University Hospitals NHS Foundation Trust) — London, United Kingdom (RECRUITING)
- St Mary's Hospital (Imperial College Healthcare NHS Trust) — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Peter Miller, MS
- Email: p.miller@shapemem.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Vascular Embolization