Splenic Artery Embolization for Splenic Injuries
(ELSA-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is splenic artery embolization using vascular plugs or coils safe for humans?
How does the treatment of splenic artery embolization using vascular embolic coils or plugs differ from other treatments for splenic injuries?
Splenic artery embolization using vascular embolic coils or plugs is unique because it allows for precise placement in the artery, which can be crucial for effective treatment. Vascular plugs, in particular, are associated with reduced fluoroscopy times (the time spent using X-ray guidance) compared to coils, potentially making the procedure quicker and more efficient.14678
What data supports the effectiveness of the treatment Splenic Artery Embolization for Splenic Injuries?
Research shows that using vascular plugs in splenic artery embolization can reduce the time needed for the procedure compared to using coils, which may lead to less radiation exposure for patients. This suggests that vascular plugs might be a more efficient option for treating splenic injuries.12346
Are You a Good Fit for This Trial?
This trial is for individuals over 15 years old who have a high-grade splenic injury from trauma, as seen on a CT scan. They must be candidates for non-surgical treatment and weigh more than 50kg. People can't join if they have severe blood clotting issues, are pregnant or breastfeeding, don't speak English, are prisoners, immunocompromised, or unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo splenic artery embolization using either vascular embolic coils or plugs
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for long-term outcomes and technical success
What Are the Treatments Tested in This Trial?
Interventions
- Vascular Embolic Coils or Plugs
Vascular Embolic Coils or Plugs is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andrew J. Gunn
Lead Sponsor
Penumbra Inc.
Industry Sponsor