Withdrawn before it began
Robot Based Tympanic Tube Placement
NCT03569943 · Assistance Publique - Hôpitaux de Paris · Updated 19 Aug 2020
- What is being tested
- Robot Based Transtympanic drain placement
- For
- Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. The full rules are on the registry page.
- Where
- Not stated
- When
- Starts or started 3 Jan 2019, ends 28 Feb 2020. Registered 26 June 2018.
- Results
- None posted yet.
In the researchers' words
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…