OSANCT02262247
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures
An observational study of OSA and Oral Disease, run by Medrobotics Corporation at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- OSA, Oral Disease, Oropharyngeal Neoplasms
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects ≥ 22 years of age requiring transoral procedures
Who may be able to join
- ≥ 22 years of age
- Candidate for transoral surgery in the oropharynx, hypopharynx and larynx
Who cannot join
- Less than 22 years of age
- Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
University Hospital of Essen
Essen, Hufelandstraße, 45147
University Hosptial Giessen and Marburg
Marburg, Baldingerstraße, 35043
University Hospital Ulm
Ulm, Baden-Wurttemberg, 89075
About this study
Official title: A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures
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.
- Conditions
- OSA, Oral Disease, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms
- Keywords
- Transoral, Oropharynx, Hypopharynx, Endoscopic, TORS, Endoscopic Transoral, Larynx
- Medical subject headings
- Mouth Diseases, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transoral Visualization & Access | Subjects ≥ 22 yrs requiring transoral procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medrobotics Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D Tricoli, BS, MBA, Study director, Medrobotics Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262247
- Sponsor's protocol ID
- FLX-ENT-PMK-OUS-001
- Status last verified
- Mar 2016
- First submitted
- 23 Sep 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures
- ClinicalTrials.gov ID
- NCT02262247
- Acronym / sponsor ID
- FLX-ENT-PMK-OUS-001
- Conditions
- OSA, Oral Disease, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms
- Keywords
- Transoral, Oropharynx, Hypopharynx, Endoscopic, TORS, Endoscopic Transoral, Larynx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medrobotics CorporationUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral Visualization & Access | – | –Subjects ≥ 22 yrs requiring transoral procedures |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 22 years of age requiring transoral procedures
Key inclusion criteria (2 listed)
- ≥ 22 years of age
- Candidate for transoral surgery in the oropharynx, hypopharynx and larynx
Key exclusion criteria (2 listed)
- Less than 22 years of age
- Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Access and Visualizaton in Oropharynx, Hypopharynx and Larynx
Time frame: Intra-Operative
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Tricoli, BS, MBA study director
Medrobotics Corp
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA and Oral Disease, run by Medrobotics Corporation at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access and Visualizaton in Oropharynx, Hypopharynx and Larynx (time frame: Intra-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.