COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Forces During Skull Base Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01705821
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
Robert Webster, Vanderbilt University

Brief Summary:
This study is designed to measure forces applied using standard surgical instruments at the skull base during resection of skull base lesions. This data will be useful for optimizing an active canula robot for assisting in skull base surgery. We hypothesize that through measurement of forces generated during routine endoscopic skull base surgery we will be able to optimize the canulas of an active canula robot for skull base surgery.

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 Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients undergoing standard endonasal skull base surgery.

Inclusion criteria:

  • Any male or female patient 18-75 years old undergoing endonasal skull base surgery for a skull base lesion.
  • Competent in decision making process and able to sign a written informed consent form.

Exclusion Criteria:

-Any patient not able to give written informed consent.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01705821

Layout table for location information
United States, Tennessee
Vanderbilt University Skull Base Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Layout table for investigator information
Principal Investigator: Robert Webster, PhD Vanderbilt University
Layout table for additonal information
Responsible Party: Robert Webster, Assistant Professor, Vanderbilt University Identifier: NCT01705821    
Other Study ID Numbers: 121194
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Robert Webster, Vanderbilt University:
Skull base
Endonasal surgery
Sinus surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases