Forces During Skull Base Surgery

NCT01705821 | Completed

• 1 other identifier: 121194
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Skull Base; Pituitary; Robotics; Endonasal Surgery; Sinus Surgery

Keywords

Skull base; Pituitary; Robotics; Endonasal surgery; Sinus surgery

Outcome Measures

Primary Outcomes (1)

• 6-axis force and torque data from routine endoscopic transnasal skull base surgery

  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.

  12 months

Secondary Outcomes (1)

• Percent tumor removal in skull and cadaver studies

  12 months

Study Arms (1)

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; Procedure: Removal of pituitary tumor using modified curette

Interventions

Use of force sensing surgical curette DEVICE

Use of a standard surgical curette outfitted with an in-line 6-axis force and torque transducer for collection of force data during surgery.

Skull Base Surgery Candidate

Removal of pituitary tumor using modified curette PROCEDURE

Skull Base Surgery Candidate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing standard endonasal skull base surgery.

You may qualify if:

• 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.

You may not qualify if:

• Any patient not able to give written informed consent.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Skull Base Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Pituitary Diseases

Condition Hierarchy (Ancestors)

Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Robert Webster, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)