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Acoustic Neuroma clinical trials

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NCT ID: NCT03261726 Withdrawn - Acoustic Neuroma Clinical Trials

Maintaining Cochlear Patency After VIIIth Nerve Surgery

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in ~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.

NCT ID: NCT03057678 Withdrawn - Acoustic Neuroma Clinical Trials

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

PPF
Start date: December 2021
Phase: N/A
Study type: Interventional

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.