Actively Recruiting
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Led by Nantes University Hospital · Updated on 2023-05-31
550
Participants Needed
14
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol. This is a three years interventional study involving adults with profound bilateral hearing loss. Eligible subjects will be randomized in two groups : robotic insertion, or manual insertion. Each patient will be followed during 12 months.
CONDITIONS
Official Title
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (age > 18)
- Eligible for a cochlear implant insertion according to the HAS recommendations
- Patient having signed an informed consent
You will not qualify if you...
- Profound hearing loss linked to meningitis
- Bilateral cochlear implants insertion during the same surgery
- Removal and re-insertion of a cochlear implant (due to a failure for example)
- Patient under guardianship or curatorship
- Contraindication to the use of the RobOtol�ae including:
- Patients wearing electronic devices directly connected to the brain or nervous system
- Medical conditions prohibiting general anesthesia
- Inability to view anatomy adequately
- Any situation that the doctor believes may pose risk
- Anticipated difficulty to comply with the investigation (job transfer, geographical distance, lack of motivation, incapacity to fulfill questionnaires)
- Patient previously included in Robiicca study (for the opposite side)
- Perimodiolar implants (not compatible with the RobOtol�ae)
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Lille University Hospital
Lille, Nord, France, 59000
Actively Recruiting
2
Bordeaux University Hospital
Bordeaux, France, 33604
Not Yet Recruiting
3
Brest University Hospital
Brest, France
Actively Recruiting
4
Chu Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
5
Hopital Bicetre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
6
AP-HM
Marseille, France
Not Yet Recruiting
7
CHRU de Montpellier
Montpellier, France
Not Yet Recruiting
8
Michel
Nantes, France
Actively Recruiting
9
CHU NICE
Nice, France
Actively Recruiting
10
AP-HP - la Pitié-Salpétrière
Paris, France
Not Yet Recruiting
11
C.H.R. Pontchaillou
Rennes, France, 35033
Not Yet Recruiting
12
CHU de Saint-Etienne
Saint-Etienne, France, 42270
Actively Recruiting
13
CHRU Hautepierre
Strasbourg, France, 67098
Not Yet Recruiting
14
CHRU de Tours
Tours, France, 37000
Not Yet Recruiting
Research Team
G
Guillaume MICHEL, PhD
CONTACT
C
Cécile Dert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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