Monday, October 26, 2026 · Daily editionET --:--:--

Withdrawn before it began

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

NCT03057678 · Vanderbilt University Medical Center · Updated 20 Jan 2022

What is being tested
Testing of Pre-Positioning Frame
For
Acoustic Neuroma
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 21 years to 80 years. The full rules are on the registry page.
Where
United States
When
Starts or started Dec 2021, ends 31 Dec 2021. Registered 20 Feb 2017.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT03057678

Sites

  • Vanderbilt University Medical CenterNashville, Tennessee, United States