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Vascular Embolic Device

Splenic Artery Embolization for Splenic Injuries (ELSA-2 Trial)

N/A
Recruiting
Research Sponsored by Andrew J. Gunn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Trauma resulting in grade III or higher splenic injury on contrast-enhanced CT
≥15 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

ELSA-2 Trial Summary

This trial will evaluate whether coils or plugs are more effective for proximal splenic artery embolization in cases of high-grade splenic trauma.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests how well two different devices—vascular embolic coils and plugs—work in blocking the splenic artery to control bleeding after serious spleen injuries. Patients will be randomly assigned one of these methods in multiple hospitals.See study design
What are the potential side effects?
Possible side effects include pain at the insertion site, bleeding complications, allergic reactions to materials used during embolization, and potential risks associated with radiation exposure from imaging techniques.

ELSA-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a severe spleen injury shown on a CT scan.
Select...
I am 15 years old or older.

ELSA-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Technical Success
Secondary outcome measures
Number of Participants Enrolled within 24 months

ELSA-2 Trial Design

2Treatment groups
Active Control
Group I: Active Comparator: Splenic artery embolization with vascular embolic coilsActive Control1 Intervention
Device: Splenic artery embolization with vascular embolic coils
Group II: Active Comparator: Splenic artery embolization with vascular embolic plugsActive Control1 Intervention
Active Comparator: Splenic artery embolization with vascular embolic plugs

Find a Location

Who is running the clinical trial?

Penumbra Inc.Industry Sponsor
35 Previous Clinical Trials
8,860 Total Patients Enrolled
Andrew J. GunnLead Sponsor

Media Library

Vascular Embolic Coils or Plugs (Vascular Embolic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05128955 — N/A
Splenic Injuries Research Study Groups: Active Comparator: Splenic artery embolization with vascular embolic coils, Active Comparator: Splenic artery embolization with vascular embolic plugs
Splenic Injuries Clinical Trial 2023: Vascular Embolic Coils or Plugs Highlights & Side Effects. Trial Name: NCT05128955 — N/A
Vascular Embolic Coils or Plugs (Vascular Embolic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128955 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are currently being treated in this medical trial?

"This trial necessitates the involvement of 250 qualifying candidates distributed across two sites, Ohio State University Medical Centre in Columbus and Wake Forest Baptist Medical Center in Winston-Salem."

Answered by AI

How many facilities are presently conducting this research trial?

"Enrollment for this trial is taking place at Ohio State University Medical Center (Columbus, OH), Wake Forest Baptist Medical Centre (Winston-Salem, NC), and Prisma Health (Greenville, SC) in addition to 5 other sites."

Answered by AI

Are there still slots available to participate in this investigation?

"According to clinicaltrials.gov, this investigation is actively looking for participants. This project was first published on May 10th 2022 and the most recent update took place on May 23rd of the same year."

Answered by AI
~0 spots leftby Apr 2024