Patient Operated on From a Vestibular Schwannoma With a Middle Ear ExclusionROBOTOLNCT03569943
Robot Based Tympanic Tube Placement
A study testing Robot Based Transtympanic drain placement in people with Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion
- What is being tested?
- Robot Based Transtympanic drain placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient candidate for exclusion of the middle ear when performing a translabyrinthine approach during a vestibular schwannoma surgery
- Patient over 18 years old
Who cannot join
- 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
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- Robot Based Transtympanic drain placement
- Keywords
- Robot based procedure, RobOtol, Tympanic drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Based Transtympanic drain placementDevice
Placement of a transtympanic drain with a robot based device assistance called RobOtol
| Study group | Role | What they receive |
|---|---|---|
| Robotol | Experimental | Not described Receives: Device: Robot Based Transtympanic drain placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain position on the tympanic membrane
Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to assess drain position
Measured: one day
Secondary outcomes (4)
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
Measured: one day
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
Measured: one day
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)
Measured: one day
Duration of installation of the robot and the procedure
Duration of installation of the robot and the procedure will be collected
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start3 Jan 2019
- Primary completion1 Jan 2020
- Study completion28 Feb 2020
Why it stopped: Change in medical practice on the management of the eligible population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Operated on From a Vestibular Schwannoma With a Middle Ear ExclusionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569943
- Sponsor's protocol ID
- P160408J
- Other IDs
- 2017-A03159-44
- Acronym
- ROBOTOL
- Status last verified
- Aug 2020
- First submitted
- 15 Jun 2018
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Trans-tympanic Aerator Using a Robotic Microsurgical Assistance Tool
- ClinicalTrials.gov ID
- NCT03569943
- Acronym / sponsor ID
- ROBOTOL / P160408J
- Keywords
- Robot based procedure, RobOtol, Tympanic drain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in medical practice on the management of the eligible population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotol | Experimental | Device: Robot Based Transtympanic drain placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient candidate for exclusion of the middle ear when performing a translabyrinthine approach during a vestibular schwannoma surgery
- Patient over 18 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot Based Transtympanic drain placementPlacement of a transtympanic drain with a robot based device assistance called RobOtol | Device | Robotol |
Primary outcome
Drain position on the tympanic membrane
Time frame: one day
Video recording of the procedure and tympanic membrane collection and microscopic analysis will used to assess drain position
4 secondary outcomes
The occurence of a bleeding intraoperative from the eardrum or from the external auditory canal
Time frame: one day
The occurence of a lesion of the tympanic membrane except the section necessary for the placement of the drain (tympanic perforation, accidental tear)
Time frame: one day
The number of contact between the cutaneous cover of the external auditory canal and the instrument of the robot
Time frame: one day
Duration of installation of the robot and the procedure
Time frame: one day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Based Transtympanic drain placement in people with Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drain position on the tympanic membrane (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.