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Robot Based Tympanic Tube Placement (ROBOTOL)

Primary Purpose

Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robot Based Transtympanic drain placement
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion focused on measuring Robot based procedure, RobOtol, Tympanic drain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient candidate for exclusion of the middle ear when performing a translabyrinthine approach during a vestibular schwannoma surgery
  • Patient over 18 years old

Exclusion Criteria:

  • Patient with psychomotor retardation or behavioral problems that preclude clinical examination
  • Patient with an external auditory canal diameter of less than 3 mm
  • Patient participating in another interventional clinical trial
  • Breastfeeding or pregnant woman
  • Patient not residing in France
  • Patient under tutorship / guardianship or under security measure
  • Patient who has not signed a written consent
  • Patient not benefiting from french national health insurance system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Robotol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Drain position on the tympanic membrane
    Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to assess drain position

    Secondary Outcome Measures

    The occurence of a bleeding intraoperative from the eardrum or from the external auditory canal
    Video recording of the procedure will used to assess this measure Yes/no answer
    The occurence of a lesion of the tympanic membrane except the section necessary for the placement of the drain (tympanic perforation, accidental tear)
    Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to tympanic lesions
    The number of contact between the cutaneous cover of the external auditory canal and the instrument of the robot
    Video recording of the procedure will used to assess this measure (number of contacts)
    Duration of installation of the robot and the procedure
    Duration of installation of the robot and the procedure will be collected

    Full Information

    First Posted
    June 15, 2018
    Last Updated
    August 17, 2020
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03569943
    Brief Title
    Robot Based Tympanic Tube Placement
    Acronym
    ROBOTOL
    Official Title
    Implantation of Trans-tympanic Aerator Using a Robotic Microsurgical Assistance Tool
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in medical practice on the management of the eligible population
    Study Start Date
    January 3, 2019 (Actual)
    Primary Completion Date
    January 1, 2020 (Actual)
    Study Completion Date
    February 28, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. 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 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; 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion
    Keywords
    Robot based procedure, RobOtol, Tympanic drain

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Robotol
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Robot Based Transtympanic drain placement
    Intervention Description
    Placement of a transtympanic drain with a robot based device assistance called RobOtol
    Primary Outcome Measure Information:
    Title
    Drain position on the tympanic membrane
    Description
    Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to assess drain position
    Time Frame
    one day
    Secondary Outcome Measure Information:
    Title
    The occurence of a bleeding intraoperative from the eardrum or from the external auditory canal
    Description
    Video recording of the procedure will used to assess this measure Yes/no answer
    Time Frame
    one day
    Title
    The occurence of a lesion of the tympanic membrane except the section necessary for the placement of the drain (tympanic perforation, accidental tear)
    Description
    Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to tympanic lesions
    Time Frame
    one day
    Title
    The number of contact between the cutaneous cover of the external auditory canal and the instrument of the robot
    Description
    Video recording of the procedure will used to assess this measure (number of contacts)
    Time Frame
    one day
    Title
    Duration of installation of the robot and the procedure
    Description
    Duration of installation of the robot and the procedure will be collected
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient candidate for exclusion of the middle ear when performing a translabyrinthine approach during a vestibular schwannoma surgery Patient over 18 years old Exclusion Criteria: Patient with psychomotor retardation or behavioral problems that preclude clinical examination Patient with an external auditory canal diameter of less than 3 mm Patient participating in another interventional clinical trial Breastfeeding or pregnant woman Patient not residing in France Patient under tutorship / guardianship or under security measure Patient who has not signed a written consent Patient not benefiting from french national health insurance system

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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