Not a traditional drug phase: WEB for Wide Neck Bifurcation Intracranial Aneurysms
A prospective, multicenter, single arm, treatment study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation.
Official registry: https://clinicaltrials.gov/study/NCT04839705 · Microvention-Terumo, Inc. · enrollment listed as 200
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are WEB. The registry lists allocation as na. A prospective, multicenter, single arm, treatment study.
They plan to enroll about 200 people at 29 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Interventions: WEB
Primary outcome (registry wording): Key Effectiveness Outcome
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Patient must be ≥ 18 at the time of screening
- Patient must have a single ruptured or unruptured IA requiring treatment
Who the registry excludes
- Patient has an IA with characteristics unsuitable for endovascular treatment
- Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
- Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 90 days
- Patient's index IA was previously treated
- Patient is pregnant
Public study contact (from the registry)
Robert Gash
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
29 listed- Memorial Health Systems — Hollywood, Florida (recruiting)
- Orlando Health Neuroscience Institute — Orlando, Florida (recruiting)
- The Queen's Medical Center Neuroscience Institute — Honolulu, Hawaii (recruiting)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa (recruiting)
- University of Kansas Health System — Kansas City, Kansas (recruiting)
- Baptist Health Systems — Lexington, Kentucky (recruiting)
- University of Kentucky, Department of Neurosurgery — Lexington, Kentucky (recruiting)
- Norton Healthcare — Louisville, Kentucky (recruiting)
- LSU Health Sciences Center at Shreveport — Shreveport, Louisiana (recruiting)
- University of Maryland, Baltimore — Baltimore, Maryland (withdrawn)
- Johns Hopkins University — Baltimore, Maryland (recruiting)
- Massachusetts General Brigham Incorporated — Boston, Massachusetts (recruiting)
FAQ about this NCT record
Is NCT04839705 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04839705?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04839705?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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