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Robot Based Tympanic Tube Placement

NCT03569943 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-08-19

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Robot Based Transtympanic drain placement

Placement of a transtympanic drain with a robot based device assistance called RobOtol

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2020-01-01
Completion
2020-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569943 on ClinicalTrials.gov