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NCT03556085 · ClinicalTrials.gov registry record · NA
Venous Sinus Stenting With the River Stent in IIH
A NA study of Idiopathic Intracranial Hypertension, sponsored by Serenity Medical.
- Active
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 6
- Study locations
NCT03556085 is a NA study of Idiopathic Intracranial Hypertension that is active but no longer recruiting, run by Serenity Medical. The registered enrollment target is 39 participants. The trial reports 6 study locations across 4 states.
The verdict
NCT03556085, a NA study of Idiopathic Intracranial Hypertension, is active but no longer recruiting, sponsored by Serenity Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 6
- Study locations
Study Summary
The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy. The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.
Conditions Studied
Interventions
- DEVICE Venous sinus stenting (Serenity River)
Study Locations (6)
New York
- UB Neurosurgery - Buffalo
- Northwell Health - Manhasset
- Weill Cornell Medicine - New York
Florida
- Baptist Health - Jacksonville
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-08-24 |
| Est. Completion | 2026-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03556085
The ClinicalTrials.gov registry entry for NCT03556085 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Serenity Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic Intracranial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Venous sinus stenting (Serenity River) is the first listed.
NCT03556085 reports 6 study locations spanning 4 distinct geographic areas - top geographies include New York, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03556085 about?
NCT03556085 is a clinical study titled "Venous Sinus Stenting With the River Stent in IIH". The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field...
What is the current status of trial NCT03556085?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 39 participants. The study started on 2018-08-24. Estimated completion is 2026-11-01.
What conditions does trial NCT03556085 study?
This clinical trial studies the following conditions: Idiopathic Intracranial Hypertension.
What interventions are being tested in trial NCT03556085?
The interventions under investigation include: Venous sinus stenting (Serenity River) (DEVICE).
Who is sponsoring clinical trial NCT03556085?
This trial is sponsored by Serenity Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03556085 being conducted?
This trial has 6 study locations across Florida, New York, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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