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

Medrobotics

Status: Completed

Conditions: Hypopharyngeal Neoplasms; Oropharyngeal Neoplasms; OSA; Oral Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02262247

FLX-ENT-PMK-OUS-001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Transoral Visualization & Access

Description:

Subjects ≥ 22 yrs requiring transoral procedures