Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion Clinical Trial
Official title:
Implantation of Trans-tympanic Aerator Using a Robotic Microsurgical Assistance Tool
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.
Description of the population to be studied and justification of its choice:
This study is going to include a single group of patients presenting a vestibular schwannoma
that will benefit from an removal by translabyrinthine approach with exclusion from the
middle ear under general anesthesia. During this surgery, the tympanic membrane is
systematically sacrificed and the inner ear opened with as consequence a complete loss of
residual hearing and vertigo for a few days. In this protocol research, the patients will
participate by accepting an robot based placement of a tympanic ventilation drain during the
surgery before the sacrifice of the tympanic membrane.
All the patients will be adults, living in France, benefiting from the cover of the French
health care system. The people participating to the research will have to give their consent
to participate to the study.
Name and brief description of one or several experimental medical devices:
The concept of the device RobOtol® is based on a teleoperated system with 6 degrees of
freedom.
The medical device is European Conformity (CE) marked since in June, 2016. The team of Ear,
Nose and Throat (ENT) of Pitié-Salpêtrière (PSL) university hospital will lead this project.
Description and justification of the methods and the duration of study:
The studied device is a drain mounted on a trocar placed by means of the teleoperated system
RobOtol.
The gold standard device and procedure is a drain inserted by the surgeon with forceps after
incision of the eardrum.
The equipment RobOtol will be driven by the surgeon. The procedure will be conducted under
general anesthesia.
Summarize of predictable and known benefits and risks for the people participating to the
study:
There is no individual expected benefit considering the choice of the included population in
the protocol. The population was chosen to eliminate the risks of unwanted effect during the
installation of the drain by the robot (in particular the risks for the tympanic membrane).
The patients presenting an indication of tympanic ventilation drain placement (ex: serous
otitis), have the exceptional risks, a hearing loss, a secondary infection of the drain or
vertigo, or facial palsy.
The population chosen in this study has to benefit from a removal of a vestibular schwannoma.
Within the procedure of this surgery, a total loss of the hearing, a sacrifice of the
tympanic membrane and vertigo are expected and predictable consequences of the surgical
technique. For that reason, there is no additional risk of complication.
The only risk is the fact that the general anesthesia will be prolonged for the study, for
approximately 15 min on a surgery requiring an average duration of anesthesia of 5,5 hours (1
hour of perioperative anesthesia, 4,5 hours of surgery).
PROGRESS OF THE SEARCH
Modalities(Methods) of recruitment:
Fifteen adults presenting a vestibular schwannoma that will benefit from a removal by
translabyrinthine approach with exclusion from the middle ear under general anesthesia will
be included after information and obtaining of their written consent.
1. Visit of selection and inclusion The recruitment of the patients will be made from the
line of the new patients by the investigators for the consultation of ENT of PSL.
Visit of selection / inclusion in the study by the ENT ( D0):
O Clinical examination: otoscopy, check of the diameter of the external auditory canal o
Check of the criteria of inclusion and non inclusion o Information of the patient o
Signature of the informed consent by the patient o Collection clinical data: sex, age,
operated side (left / right), previous otological history, diameter of the external
auditory canal
2. Visit of follow-up of the study
The intervention by the ENT (D14):
The intervention will take place in the operating room of the building Babinski and the
service of ENT;
3. Visit of the end of the research There is no visit of post-operative follow-up nor visit
of the end of planned research.
The patient sees his participation in the research ending after the removal of the tympanic
membrane at D0.
;