nOCT Imaging for Brain Aneurysm
(INSYTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging device called the nOCT Imaging System, which helps doctors view blood vessels in the brain during treatment for brain aneurysms (bulging blood vessels). The goal is to ensure the device safely and effectively provides clear images to assist in treatment decisions. Patients already planning to undergo brain aneurysm treatment and meeting certain medical criteria might be suitable for this study. The device uses a small, flexible probe connected to a console, displaying detailed pictures for doctors to use during and after the procedure. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future treatment options.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have an allergy or contraindication to heparin, iodinated contrast, or dual-antiplatelet medication, you may not be eligible to participate.
What prior data suggests that the nOCT Imaging System is safe for use in brain aneurysm procedures?
Research into the nOCT Imaging System, which creates images from inside brain blood vessels, suggests it effectively maps the brain. Although still under study and not yet FDA-approved for general use, research has focused on its ability to provide clear images during procedures. The nOCT System has received FDA IDE approval, allowing testing in clinical trials to ensure safety and efficacy.
Current information does not specifically mention any side effects or problems. However, FDA IDE approval suggests early evaluations indicate the device is reasonably safe for study use. This approval permits testing on people under controlled conditions to gather more safety information. As it remains in the trial phase, further data will confirm its tolerance during procedures.12345Why are researchers excited about this trial?
Researchers are excited about the nOCT Imaging System because it offers a new way to visualize brain aneurysms during treatment. Unlike traditional imaging methods like CT or MRI scans, nOCT provides real-time, high-resolution images that can help doctors see the intricate details of aneurysms with greater clarity. This could potentially lead to more precise and effective treatments, reducing the risk of complications. By offering clearer insights during both the treatment and follow-up stages, nOCT could enhance patient outcomes significantly.
What evidence suggests that the nOCT Imaging System is effective for brain aneurysm diagnosis and treatment?
Research has shown that the nOCT Imaging System captures clear images of blood vessels in the brain. These images assist doctors in examining the vessels for diseases or devices. Early results suggest that nOCT provides detailed, real-time views during brain aneurysm procedures, aiding doctors in making better decisions and performing procedures more accurately. The system also reveals how tissue grows over implants, which may assist with follow-up care. Overall, nOCT appears promising in enhancing the treatment of brain aneurysms by offering improved imaging information.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 75 who are scheduled for a planned treatment of a brain aneurysm (ruptured or unruptured), have certain blood vessel sizes, can understand the procedure, and agree to follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Use of the nOCT Imaging System during intracranial aneurysm treatment to obtain diagnostic images
Follow-up
Participants are monitored for safety and effectiveness, including image quality assessment
What Are the Treatments Tested in This Trial?
Interventions
- nOCT Imaging System
Trial Overview
The study is testing the safety and usefulness of the nOCT Imaging System—a device that takes detailed pictures inside brain blood vessels—during minimally invasive procedures to treat brain aneurysms.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Use of nOCT during intracranial aneurysm treatment and subsequent follow-up
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spryte Medical
Lead Sponsor
Citations
Intravascular Neuro OCT Imaging System for Aneurysm ...
The objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during ...
FDA IDE Approval for INSYTE nOCT Brain Aneurysm Trial
The trial will evaluate the safety and effectiveness of Spryte's neuro Optical Coherence Tomography (nOCT) imaging system for use during intracranial aneurysm ...
Announcement of Spryte Medical, a US Affiliate of NIPRO
“Our goal with nOCT is to provide clinicians with a new level of intravascular insight that may ultimately improve decision-making, procedural ...
Development, image interpretation, clinical experience, ...
(D) nOCT imaging of an aneurysm neck remnant at follow- up reveals tissue growth across the flow- diverter struts (white arrow), while small.
5.
evtoday.com
evtoday.com/news/insyte-trial-begins-for-sprytes-neuro-oct-imaging-system-for-intracranial-aneurysm-proceduresINSYTE Trial Begins for Spryte's Neuro OCT Imaging ...
INSYTE will evaluate the Spryte's nOCT imaging system during endovascular intracranial aneurysm treatment and follow-up.
6.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/fda-approves-sprytes-pivotal-aneurysm-imaging-trial/FDA Approves Spryte's Pivotal Aneurysm Imaging Trial
Spryte Medical secured FDA IDE approval to launch INSYTE, a pivotal trial evaluating its neuro optical coherence tomography system as an ...
Spryte Medical Receives FDA IDE Approval to Initiate ...
The trial will evaluate the safety and effectiveness of Spryte's neuro Optical Coherence Tomography (nOCT) imaging system for use during ...
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