NCT07214220 · Spryte Medical
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
(INSYTE)
What this study is about
This is an experimental study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices.
View original scientific description
This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices. The nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing. 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 endovascular intracranial aneurysm treatment and follow-up.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject age ≥ 18 and ≤ 75 years Subject has a pre-procedure mRS ≤ 3 Subject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured Subject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document Parent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.
Exclusion criteria
- Subjects with a minimum platelet count of \< 100,000/μL. Subjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days. Subject has an acutely ruptured aneurysm with a Hunt \& Hess score ≥ 4 Subject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography Subject has challenging anatomy that in the investigator's opinion is not suitable for safe delivery of an 0.021" catheter, including stenosis \> 70% or excessive tortuosity Subject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year Subject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements. Subject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke Subject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication Subject has ipsilateral carotid or vertebral artery stenosis greater than 50% Subject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment. Subject has serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk Subject has severe intracranial vasospasm not responsive to medical therapy Subject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis The subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial Subject is currently participating in another clinical research trial involving an investigational device or drug Subject is under judicial protection or legal guardianship
Where
- Jacksonville, Florida
- Tampa, Florida
- Park Ridge, Illinois
- Boston, Massachusetts
- Buffalo, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations