A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures

NCT ID: NCT02262247

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

Brief Summary

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The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.

Detailed Description

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Conditions

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OSA Oral Disease Oropharyngeal Neoplasms Hypopharyngeal Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Transoral Visualization & Access

Subjects ≥ 22 yrs requiring transoral procedures

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ≥ 22 years of age
* Candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Exclusion Criteria

* Less than 22 years of age
* Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medrobotics Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael D Tricoli, BS, MBA

Role: STUDY_DIRECTOR

Medrobotics Corp

Locations

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University Hospital of Louvain at Mont-Godinne

Yvoir, , Belgium

Site Status

University Hospital Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status

University Hosptial Giessen and Marburg

Marburg, Baldingerstraße, Germany

Site Status

University Hospital of Essen

Essen, Hufelandstraße, Germany

Site Status

Countries

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Belgium Germany

Other Identifiers

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FLX-ENT-PMK-OUS-001

Identifier Type: -

Identifier Source: org_study_id

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