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Neuroma, Acoustic clinical trials

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NCT ID: NCT03569943 Withdrawn - Clinical trials for Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion

Robot Based Tympanic Tube Placement

ROBOTOL
Start date: January 3, 2019
Phase: N/A
Study type: Interventional

Middle ear surgery is performed in a deep workspace through a narrow approach to the tympanic cavity, either by the external auditory canal, or by drilling the temporal bone. It uses thin and long instruments as a delicate and precise gesture on the ossicular chain or manipulation of very light prostheses is necessary. The results of middle ear procedures relies upon the surgeon experience and his gesture accuracy. For this reason, a robot-based device designed to assist the surgeon during middle ear procedure has been build. The goal of the present protocol is to evaluate the robot in a simple procedure to ensure its safety before using the device in more complex cases. The precision of the robot during transtympanic tube placement will be evaluated. The following benefits are expected: - Significantly reduced risk of transtympanic tube on the other side of the eardrum. - Positioning of the transtympanic tube in the desired tympanic quadrant - Reduces the size of the entry point to prevent tearing - Reduced risk of injury to the external auditory canal Once the safety of use of the robot is demonstrated in this protocol, the goal will be to evaluate it later in more complex surgical gestures in other protocols. The future application of the robot will be the placement of middle ear implant prosthesis in the context of the surgery for cholesteatoma, otosclerosis or insertion of cochlear implants.

NCT ID: NCT03261726 Withdrawn - Acoustic Neuroma Clinical Trials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.

NCT ID: NCT02415257 Withdrawn - Clinical trials for Vestibular Schwannoma

Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Start date: April 2015
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques

NCT ID: NCT02379754 Withdrawn - Clinical trials for Vestibular Schwannoma

Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.

NCT ID: NCT02194452 Withdrawn - Adult Glioblastoma Clinical Trials

Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors

Start date: September 2013
Phase: N/A
Study type: Interventional

This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.