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

NCT03057678 | Withdrawn

• 2 other identifiers: 151347R01DC012593
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acoustic Neuroma

Outcome Measures

Primary Outcomes (2)

• Time in minutes required to attach the PPF.

  From PPF anchored to temporal bone until bone screws are loosened and PPF removed, estimated 15-30 minutes.

• Percentage of planned mastoidectomy reachable by robot

  During the use of the PPF, estimated 15-30 minutes.

Study Arms (1)

Testing of Pre-Positioning Frame

EXPERIMENTAL

Placement of bone screws, CT scanning, Surgical planning, Robot motion planning

Other: Testing of Pre-Positioning Frame

Interventions

Testing of Pre-Positioning Frame OTHER

Placement of bone screws, CT scanning, Surgical planning, Robot motion planning

Testing of Pre-Positioning Frame

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; 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

Study Officials

• Robert F. Labadie, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Robert J. Webster, PhD

  Vanderbilt University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Chief Research Officer, Professor of Otolaryngology-Head and Neck Surgery, Professor of Biomedical Engineering

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)