Forces During Skull Base Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Robert Webster, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01705821
First received: October 8, 2012
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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 Intervention
Skull Base
Pituitary
Robotics
Endonasal Surgery
Sinus Surgery
Device: Use of force sensing surgical curette
Procedure: Removal of pituitary tumor using modified curette

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Forces Applied During Skull Base Surgery

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 6-axis force and torque data from routine endoscopic transnasal skull base surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Percent tumor removal in skull and cadaver studies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adult patients undergoing standard endonasal skull base surgery.

Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705821

Contacts
Contact: Robert Webster, PhD 6153432898 robert.webster@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Skull Base Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: James Bekeny, MD       james.r.bekeny@vanderbilt.edu   
Principal Investigator: Robert Webster, PhD         
Sub-Investigator: Paul Russell, MD         
Sub-Investigator: Kyle Weaver, MD         
Sub-Investigator: James Bekeny, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Robert Webster, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Robert Webster, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01705821     History of Changes
Other Study ID Numbers: 121194
Study First Received: October 8, 2012
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Skull base
Pituitary
Robotics
Endonasal surgery
Sinus surgery

ClinicalTrials.gov processed this record on August 28, 2014