ClinicalTrials.gg
Status unknownNCT06365554Updated Apr 15, 2024

On-Premise and Remote Robotic Neurointervention

An interventional study of Remedy Robot in Cerebrovascular Disease, sponsored by Remedy Robotics, Inc.. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Remedy Robotics, Inc. · Not applicable, Interventional, and Device feasibility

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Cerebrovascular Disease
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In context

Cerebrovascular Disorders

385 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's planned enrollment of 10 is below the median of 109 across 224 interventional studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

This is the only study on the registry with Remedy Robotics, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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)

People with any of the following medical history:

  • Active malignancy
  • Known contrast allergy
  • Height > 190cm
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Group undergoing intervention with the Remedy Robot.

    Device: Remedy Robot

Interventions

  • DeviceRemedy Robot

    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.

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What researchers measure

Primary outcomes

  1. Procedural safety

    Incidence of intra- and peri-procedural events, including all cause mortality, stroke, arterial dissection, arterial perforation

    Time frame: Measured from the start of the procedure through 24 hours or discharge

  2. Procedural Technical Success

    Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual control

    Time frame: Measured from the start of the procedure through to the completion of the procedure

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2024; primary completion for Jan 2025, 7 months later.

Of 100 interventional studies with no phase under Cerebrovascular Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2024
First posted
Apr 15, 2024
StartEst.
Jun 1, 2024
Primary completionEst.
Jan 1, 2025
CompletionEst.
Jun 1, 2025
Last update
Apr 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06365554
Lead sponsor
Remedy Robotics, Inc.
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Apr 15, 2024

Study contacts

David Bell, MD
Contact
david@remedyrobotics.com
650-441-5019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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