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Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

NCT ID: NCT04865718

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-27

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing cerebral blood flow during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.

Detailed Description

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Conditions

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Aneurysm, Brain Arteriovenous Malformation of Brain Neurovascular Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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neurovascular surgery group

Subjects undergoing neurovascular surgery including aneurysm clipping

ICGA imaging

Intervention Type DIAGNOSTIC_TEST

subjects undergoing intraoperative ICGA imaging

Interventions

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ICGA imaging

subjects undergoing intraoperative ICGA imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults (18 years or older).
* Size of craniotomy at least 2 cm.
* Possibility of intraoperative ICGA.
* Able to render written informed consent.

Exclusion Criteria

* Patients unable to legally consent.
* Patients with impaired cognitive function.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dell Seton Medical Center

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew Dunn, PhD

Role: CONTACT

Phone: 512-232-2808

Email: [email protected]

Kristina Adrean, RN

Role: CONTACT

Phone: 512-324-9999

Email: [email protected]

Facility Contacts

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Kristina Adrean

Role: primary

Other Identifiers

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2018040045

Identifier Type: -

Identifier Source: org_study_id