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Minimally-Invasive Venogram for Intracranial Venous Hypertension

N/A
Recruiting
Led By Kyle Fargen, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during venogram, up to 10 minutes
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new minimally-invasive treatment for Idiopathic Intracranial Hypertension (IIH). The purpose is to document normal intracranial venous sinus pressures. Those with IIH often experience headaches and visual problems. This new treatment involves going through the veins in the neck to the sinuses in the brain. It is minimally-invasive and will not require any extra visits.

Who is the study for?
This trial is for individuals who are scheduled for an elective cerebral angiogram and do not have a history of severe daily headaches, idiopathic intracranial hypertension, or a body mass index over 35. It excludes those with heart failure, pulmonary hypertension, intracranial venous pathology, or pregnancy due to radiation risks.Check my eligibility
What is being tested?
The study aims to measure normal brain vein pressures during a cerebral angiogram in the interventional radiology suite. This will help understand pressure levels in patients without Idiopathic Intracranial Hypertension (IIH), which causes increased brain pressure and symptoms like headaches.See study design
What are the potential side effects?
Since participants are already undergoing an angiogram for other medical reasons, there may be no additional side effects from this study itself. However, typical risks associated with angiograms include bleeding at the catheter site, infection, or allergic reactions to contrast dye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during venogram, up to 10 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and during venogram, up to 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Central Venous Pressures
Dominant Internal Jugular Vein
Dominant Sigmoid Sinus
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venogram GroupExperimental Treatment1 Intervention
Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,227 Total Patients Enrolled
Kyle Fargen, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Venogram Group Clinical Trial Eligibility Overview. Trial Name: NCT03948971 — N/A
Intracranial Venous Hypertension Clinical Trial 2023: Venogram Group Highlights & Side Effects. Trial Name: NCT03948971 — N/A
Venogram Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03948971 — N/A
Intracranial Venous Hypertension Research Study Groups: Venogram Group

Frequently Asked Questions

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

Is this clinical trial available to individuals aged 60 and beyond?

"Eligible participants for this medical trial must be over 18 and under the age of 60."

Answered by AI

Are participants being actively sought for this research endeavor?

"Affirmative. Sources from clinicaltrials.gov confirm that the trial, which was initially posted on January 13th 2020, is currently seeking applicants. The study needs to recruit 10 individuals at a single site."

Answered by AI

How many people have enrolled in this trial?

"Affirmative. Evident on clinicaltrials.gov, this medical experiment is currently in search of participants and was first published on January 13th 2020. Patients are being sourced from 1 site to reach a total number of 10 individuals by May 31st 2022."

Answered by AI

Who meets the criteria to join this research study?

"Qualifying for this trial necessitates that patients have intracranial venous pressures and fall between the ages of 18-60. At present, 10 participants are being sought out."

Answered by AI
~0 spots leftby May 2024