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Evaluating the Pre-Positioning Frame for Robotic Acoustic Neuroma Removal Surgery (PPF)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03057678
Recruitment Status : Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : January 25, 2021
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Robert F. Labadie, Vanderbilt University Medical Center

Brief Summary:
Otologic surgery often involves a mastoidectomy to safely access the inner ear. In this procedure, a portion of the mastoid part of the temporal bone is removed. The surgery is lengthy and challenging because many critical structures are embedded in the mastoid and are difficult to identify and accurately remove with a surgical drill. In previous work, the investigators developed a compact, bone-attached robot to automate mastoidectomy drilling for translabyrinthine acoustic neuroma removal (TANR). The robot does not attach directly to the bone. Instead, a rigid surgical fixture which the investigators call a prepositioning frame (PPF) is attached to the temporal bone, and the robot attaches to the PPF. Attaching the robot to the participant eliminates the need for an expensive image guidance system to compensate for participant motion, but requires a compact robot with a limited range of motion. The PPF supports the robot on the head such that a planned mastoidectomy volume is within the robot's range of motion. In this study, the investigators plan to test the PPF by attaching it to ten participants. By processing an intraoperative CT scan of the attached PPF, the investigators will measure the percentage of each planned mastoidectomy that would be reachable if the robot were attached. The investigators will also measure the time required to attach the PPF. The data the investigators acquire will enable further improvements to the PPF design, which would be advantageous before proceeding to robotic drilling experiments.

Condition or disease Intervention/treatment Phase
Acoustic Neuroma Other: Testing of Pre-Positioning Frame Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Basic Science
Official Title: Evaluating the Pre-Positioning Frame for Robotic Acoustic Neuroma Removal Surgery
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Testing of Pre-Positioning Frame
Placement of bone screws, CT scanning, Surgical planning, Robot motion planning
Other: Testing of Pre-Positioning Frame
Placement of bone screws, CT scanning, Surgical planning, Robot motion planning

Primary Outcome Measures :
  1. Time in minutes required to attach the PPF. [ Time Frame: From PPF anchored to temporal bone until bone screws are loosened and PPF removed, estimated 15-30 minutes. ]
  2. Percentage of planned mastoidectomy reachable by robot [ Time Frame: During the use of the PPF, estimated 15-30 minutes. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 21-80 years old undergoing TANR who consent to participation.
  • Preop Head CT scan as part of routine care.
  • Skull thickness a minimum of 3.75mm in planned attachment areas.

Exclusion Criteria:

  • Pregnant women. As per standard of care in preparation for surgery, all females of childbearing age will undergo a pregnancy test during the medical evaluation for surgery.
  • Patients with severe comorbidities, such as chronic otitis media, history of stroke, brain trauma, or hydrocephalus.
  • Patients with a history of allergic reactions to lidocaine.
  • Patients with severe anatomical abnormality of the temporal bone.
  • Patients with history of allergic reaction to titanium, because the bone screws used in this study are made of a titanium alloy.
  • Patients who are at unacceptable risk for general anesthesia.
  • Patients who are at unacceptable risk for the intraoperative CT scan(s).
  • Patients who are unable to give 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): NCT03057678

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Contact: Robert F. Labadie, MD, PhD 615-936-2493
Contact: Kate Von Wahlde, MJ, CCRP 615-322-0333

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
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Principal Investigator: Robert F. Labadie, MD, PhD Vanderbilt University Medical Center
Study Director: Robert J. Webster, PhD Vanderbilt University
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Responsible Party: Robert F. Labadie, Vice Chair, Chief Research Officer, Professor of Otolaryngology-Head and Neck Surgery, Professor of Biomedical Engineering, Vanderbilt University Medical Center Identifier: NCT03057678    
Other Study ID Numbers: 151347
R01DC012593 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroma, Acoustic
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases