Clinical trial NCT05018338: Brain-Shift Monitoring Using 3D Scanning
Official title: Pre-pilot Study of Brain-Shift Monitoring Using 3D Scanning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Craniotomy for Epilepsy and Malignant Tumor Removal
Lead sponsor: Advanced Scanners Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects seen by Dr. Anat I. Patel (neurosurgeon) and scheduled for craniotomy at St. David's North Austin Medical Center are the potential population for this study.

Brief summary: A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery.

The primary objective is to evaluate the performance of the scanner in determining the brain surface shape over multiple time points during craniotomies (surgical opening into the skull), and present those shapes in full color, with high resolution in all three coordinates of 3D space. A secondary objective is to use the measurements to determine brain shift as a function of time.

Detailed description: The scanner sterilization will largely follow procedures used currently for cameras and microscopes: the scanner will be draped in a disposable drape custom manufactured for the device by a leading instrument drape manufacturer (Medline). The drape will be windowed with a sterilized shatterproof plastic optical window. Standard hospital procedures will be followed for the disposal of instrument drapes. The drape will be sterile and wrapped in the conventional manner, and the drape itself will be disposable. Prior to surgery, the drape, window and frame will undergo the same sterilization procedure as other equipment. If window transparency is compromised during surgery, it can be cleaned with a cleaning agent.

The scanner will illuminate the craniotomy region with light for the duration of its use, which may be for the duration of the surgery. The scanner will be anywhere from 8 to 12 inches away from the patient, illuminating the subject's brain by the scanner light for 2 minutes at a time, or continuously, either with or without maximum overhead lighting.

For each patient, the duration of obtaining data will last for the duration of the clinical operation procedure. The 3D Scanner on and off time would add less than 5 minutes to the procedure, not including measurement time.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 6 years of age at Visit 1.
2. Clinically planned for craniotomy, including for malignant tumors, whether awake or under general anesthesia.
3. Able to provide written informed consent (and assent when applicable) - by subject or subject's legal representative - and agrees to comply with the requirements of the study.

Exclusion Criteria:

1. Language problems that would prevent from properly understanding instructions.
2. Requirement of an interpreter.
3. Patients who are excluded from consideration for the clinical operation are therefore excluded from the research study.
4. Special populations: pregnant women, prisoners.

Primary outcomes:
measure: Brain-shift measurement
timeFrame: Throughout the surgical procedure
Secondary outcomes:
measure: Brain-shift measurement accuracy
timeFrame: Throughout the surgical procedure
Other outcomes:
measure: Operation of the 3D scanner
timeFrame: Throughout the surgical procedure
Locations:
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
Study officials:
affiliation: Advanced Scanners Inc.
name: Aaron Bernstein, PhD
role: STUDY_DIRECTOR
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citation: Arlt F, Chalopin C, Muns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007/s00701-016-2738-z. Epub 2016 Feb 16.