AnatomyNCT06078878
Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
A study testing HF-OCT Imaging System with Vis-M Micro-Imaging Catheter in people with Anatomy, run by Gentuity, LLC at 1 site in Argentina.
Trial summary
This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomy
- What is being tested?
- HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 13 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
- Patients that present with a Modified Rankin Score (mRS) ≤3
- Patients 18 years of age or older
- Patients willing and able to provide written informed consent to participate in evaluation
Who cannot join
- Patients with 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
- Pregnant
- Patient has a known hypersensitivity to contrast media
- Patients undergoing an urgent or emergent neurointerventional procedure
- Patients that present with a Modified Rankin Score (mRS) ≥4
- Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage
- Participation in another clinical trial of an investigational drug or device
- Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Clínica La Sagrada Familia
Buenos Aires, C1428ARJ
Pedro Lylyk, MD, +54 11 4787-2220, info@lylyk.com.ar
About this study
This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.
Read the detailed description
Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.
- Conditions
- Anatomy
- Being tested
- HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-OCT Imaging System with Vis-M Micro-Imaging CatheterDevice
Subjects undergo HF-OCT imaging of the desired intravascular segement
| Study group | Role | What they receive |
|---|---|---|
| Neurovascular Imaging | Experimental | Use of the Gentuity HF-OCT Imaging System with Vis-M Micro-Imaging Catheter ("Gentuity Neurovascular Imaging System") as a diagnostic tool for intravascular imaging in the cerebrovasculature. Receives: Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety
Incidence and severity of device-related adverse events.
Measured: 7 days
Secondary outcomes (2)
Clinical performance
Operator evaluation of performance via Likert scale.
Measured: 1 day
Technical performance
Clear image length (CIL) of the vessel
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start13 Feb 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnatomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gentuity, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Lylyk, MD, Principal investigator, Clínica La Sagrada Familia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078878
- Sponsor's protocol ID
- 003818
- Status last verified
- Mar 2025
- First submitted
- 2 Oct 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
- ClinicalTrials.gov ID
- NCT06078878
- Acronym / sponsor ID
- 003818
- Conditions
- Anatomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gentuity, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.
Detailed description
Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurovascular Imaging | Experimental | Device: HF-OCT Imaging System with Vis-M Micro-Imaging CatheterUse of the Gentuity HF-OCT Imaging System with Vis-M Micro-Imaging Catheter ("Gentuity Neurovascular Imaging System") as a diagnostic tool for intravascular imaging in the cerebrovasculature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
- Patients that present with a Modified Rankin Score (mRS) ≤3
- Patients 18 years of age or older
- Patients willing and able to provide written informed consent to participate in evaluation
Key exclusion criteria (8 listed)
- Patients with 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
- Pregnant
- Patient has a known hypersensitivity to contrast media
- Patients undergoing an urgent or emergent neurointerventional procedure
- Patients that present with a Modified Rankin Score (mRS) ≥4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF-OCT Imaging System with Vis-M Micro-Imaging CatheterSubjects undergo HF-OCT imaging of the desired intravascular segement | Device | Neurovascular Imaging |
Primary outcome
Device Safety
Time frame: 7 days
Incidence and severity of device-related adverse events.
2 secondary outcomes
Clinical performance
Time frame: 1 day
Technical performance
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro Lylyk, MD principal investigator
Clínica La Sagrada Familia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF-OCT Imaging System with Vis-M Micro-Imaging Catheter in people with Anatomy, run by Gentuity, LLC at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Timberlake, MSHS ((617) 957-1434, stimberlake@gentuity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.