Cerebrovascular DiseaseNCT06365554
On-Premise and Remote Robotic Neurointervention
A study testing Remedy Robot in people with Cerebrovascular Disease, run by Remedy Robotics, Inc..
Trial summary
This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Remedy Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is ≥ 18 years of age
- The Investigator deems the patient appropriate for manual and robotic-assisted Neurointervention.
- The patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Who cannot join
- Patients currently pregnant or breastfeeding.
- People with any of the following vascular history:
- Known congenital aortopathy, connective tissue disorder or vasculopathy
- Known arterial dissection of any kind
- Bleeding diathesis
- Use of Warfarin, IV Heparin, Clexane, Fondaparinux or any new oral anticoagulants (NOACs) or direct oral anticoagulants (DOACs)
Show all 10Show fewer
- People with any of the following medical history:
- Active malignancy
- Known contrast allergy
- Height > 190cm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Feasibility of On-Premise and Remote Robotic Neurointervention
This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.
Read the detailed description
This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.
- Conditions
- Cerebrovascular Disease
- Being tested
- Remedy Robot
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remedy RobotDevice
A trained Neurointerventionalist will operate the Remedy Robot from a computer-based user interface in a room adjacent to the patient. An entire cerebral angiogram or cerebral embolization will be performed, excluding insertion and removal of the femoral sheath.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Group undergoing intervention with the Remedy Robot. Receives: Device: Remedy Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural safety
Incidence of intra- and peri-procedural events, including all cause mortality, stroke, arterial dissection, arterial perforation
Measured: Measured from the start of the procedure through 24 hours or discharge
Procedural Technical Success
Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual control
Measured: Measured from the start of the procedure through to the completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Remedy Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365554
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of On-Premise and Remote Robotic Neurointervention
- ClinicalTrials.gov ID
- NCT06365554
- Acronym / sponsor ID
- 2
- Conditions
- Cerebrovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Remedy Robotics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Unity Health Toronto
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Apr 2024 (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, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.
Detailed description
This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Remedy RobotGroup undergoing intervention with the Remedy Robot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is ≥ 18 years of age
- The Investigator deems the patient appropriate for manual and robotic-assisted Neurointervention.
- The patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Key exclusion criteria (10 listed)
- Patients currently pregnant or breastfeeding.
- People with any of the following vascular history:
- Known congenital aortopathy, connective tissue disorder or vasculopathy
- Known arterial dissection of any kind
- Bleeding diathesis
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 |
|---|---|---|
| Remedy RobotA trained Neurointerventionalist will operate the Remedy Robot from a computer-based user interface in a room adjacent to the patient. An entire cerebral angiogram or cerebral embolization will be performed, excluding insertion and removal of the femoral sheath. | Device | Intervention Group |
Primary outcome
Procedural safety
Time frame: Measured from the start of the procedure through 24 hours or discharge
Incidence of intra- and peri-procedural events, including all cause mortality, stroke, arterial dissection, arterial perforation
Procedural Technical Success
Time frame: Measured from the start of the procedure through to the completion of the procedure
Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Remedy Robot in people with Cerebrovascular Disease, run by Remedy Robotics, Inc..
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Bell, MD (650-441-5019, david@remedyrobotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural safety (time frame: Measured from the start of the procedure through 24 hours or discharge). The study lists 2 primary outcomes in all. 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 15 Apr 2024.