NCT02262247

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

September 23, 2014

Last Update Submit

March 14, 2016

Conditions

OSAOral DiseaseOropharyngeal NeoplasmsHypopharyngeal Neoplasms

Keywords

TransoralOropharynxHypopharynxEndoscopicTORSEndoscopic TransoralLarynx

Outcome Measures

Primary Outcomes (1)

  • Access and Visualizaton in Oropharynx, Hypopharynx and Larynx

    Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.

    Intra-Operative

Study Arms (1)

Transoral Visualization & Access

Subjects ≥ 22 yrs requiring transoral procedures

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects ≥ 22 years of age requiring transoral procedures

You may qualify if:

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

You may not qualify if:

  • Less than 22 years of age
  • Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital of Louvain at Mont-Godinne

Yvoir, 5530, Belgium

Location

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location

University Hosptial Giessen and Marburg

Marburg, Baldingerstraße, 35043, Germany

Location

University Hospital of Essen

Essen, Hufelandstraße, 45147, Germany

Location

MeSH Terms

Conditions

Mouth DiseasesOropharyngeal NeoplasmsHypopharyngeal NeoplasmsLaryngeal Diseases

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesOtorhinolaryngologic DiseasesRespiratory Tract Diseases

Study Officials

  • Michael D Tricoli, BS, MBA

    Medrobotics Corp

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 13, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)DE(3)