Forces During Skull Base Surgery
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|ClinicalTrials.gov Identifier: NCT01705821|
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : December 9, 2014
|Condition or disease||Intervention/treatment|
|Skull Base Pituitary Robotics Endonasal Surgery Sinus Surgery||Device: Use of force sensing surgical curette Procedure: Removal of pituitary tumor using modified curette|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Measuring Forces Applied During Skull Base Surgery|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Skull Base Surgery Candidate
Patient with a skull base lesion will undergo use of standard surgical curette with force sensor built into shaft. 6-axis force and torque data will be collected during the surgical procedure.
Device: Use of force sensing surgical curette
Use of a standard surgical curette outfitted with an in-line 6-axis force and torque transducer for collection of force data during surgery.
Procedure: Removal of pituitary tumor using modified curette
- 6-axis force and torque data from routine endoscopic transnasal skull base surgery [ Time Frame: 12 months ]This data will be collected and recorded via a computer interface with our sensorized tool and recorded in standard units for force and torque. We will also look at the variability of forces between patients after collecting this data. The data will be useful in optimizing a robotic system for endonasal surgery as described in the secondary outcome measure.
- Percent tumor removal in skull and cadaver studies [ Time Frame: 12 months ]The force and torque data will allow our team of Engineers to optimize our robotic system to be best suited for removing pituitary tumors transnasally. The robot consists of specially designed flexible arms with end effectors that each need to be able to withstand and produce the necessary forces to complete pituitary tumor excision. This will be measured by optimizing our robot based on the findings in the primary outcome measure and then evaluating the robot for efficiency and effectiveness of mock pituitary tumor removal from skull and cadaver specimens. We will investigate percent tumor removal and speed of tumor removal once the robot is optimized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705821
|United States, Tennessee|
|Vanderbilt University Skull Base Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Robert Webster, PhD||Vanderbilt University|