NCT07140731RecruitingNot Applicable
An Early Feasibility Study for the Symani Surgical System
Jacobs institute2 sites in 1 country15 target enrollmentStarted: September 20, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- CT Imaging
Study Overview
Brief Summary
A research study for a neurosurgical procedure in adult patients with Moyamoya disease
Detailed Description
The purpose of this research is to assess the safety and effectiveness of the Symani Surgical System in adult patients with Moyamoya disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged >
- •Moyamoya disease with minor to moderate symptoms requiring neurosurgical treatment.
- •Patients agree to have the surgery and the anesthesia.
- •Patients who voluntarily decide to participate in this study with the surgery performed with the aid of Symani and agree to sign the Informed Consent Form.
Exclusion Criteria
- •Patients who have bleeding or coagulation disorders in the past or present.
- •Any criteria that preclude prolonged anesthesia.
- •Hemodynamically unstable neurological exam.
- •Pressure dependent neurologic status.
Outcomes
Primary Outcomes
CT Imaging
Time Frame: 6 Months
Stable cerebral perfusion confirmed with CT Imaging
Secondary Outcomes
No secondary outcomes reported
Investigators
Adnan Siddiqui
Principal Investigator
Jacobs institute
Study Sites (2)
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