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Oropharyngeal NeoplasmsNCT02792322

Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

A study testing Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device in people with Oropharyngeal Neoplasms and Head and Neck Cancer, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci\® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Oropharyngeal Neoplasms, Head and Neck Cancer
What is being tested?
Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
11 Jul 2016to 7 May 2024
Phase
Interventional
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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
  • Written informed consent.
  • Pre-Operative Exclusion Criteria:
  • Unexplained fever and/or untreated, active infection.
  • Patient pregnancy.
  • Previous head and neck surgery precluding robotic procedures.
Show all 11Show fewer
  • The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
  • Intra-Operative Exclusion Criteria:
  • It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:
  • Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position.
  • In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Pilot Study Assessing Robotic Surgery in the Seated or Supine Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical Systems and Modified Transoral Instrumentation

This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci\® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

Read the detailed description

The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.

Being tested
Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Keywords
Cancer, Oropharynx
Medical subject headings
Oropharyngeal Neoplasms, Head and Neck Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System deviceDevice

    Also called Da Vinci Robotic Surgical Systems

    Patient's will be having TORS surgery in a seated position

Study groups in NCT02792322
Study groupRoleWhat they receive
Trans Oral Robotic Surgery (TORS)OtherPatient's are having TORS surgery in a seated position
Receives: Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TORS surgery completion in the seated position

    Recording how many participants' surgery was completed in the seated position

    Measured: Measures assessed at time of intervention (during surgery)

Secondary outcomes (2)

  1. Length of participants' surgical time

    Surgical start and stop times are recorded in the medical record

    Measured: Measures assessed at time of intervention (during surgery)

  2. Estimated amount of blood loss during participants' surgery

    Record blood loss during surgery as estimated by the lead surgeon

    Measured: Measures assessed at time of intervention (during surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion7 May 2024
  4. Study completion7 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02792322
Sponsor's protocol ID
16-001297
Other IDs
NCI-2022-10968
Status last verified
Aug 2024
First submitted
19 May 2016
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moore EJ, Olsen SM, Laborde RR, Garcia JJ, Walsh FJ, Price DL, Janus JR, Kasperbauer JL, Olsen KD. Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. Mayo Clin Proc. 2012 Mar;87(3):219-25. doi: 10.1016/j.mayocp.2011.10.007.

    PubMed 22386176

  • Weinstein GS, O'Malley BW Jr, Magnuson JS, Carroll WR, Olsen KD, Daio L, Moore EJ, Holsinger FC. Transoral robotic surgery: a multicenter study to assess feasibility, safety, and surgical margins. Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2.

    PubMed 22752997

  • Matjasko J, Petrozza P, Cohen M, Steinberg P. Anesthesia and surgery in the seated position: analysis of 554 cases. Neurosurgery. 1985 Nov;17(5):695-702. doi: 10.1227/00006123-198511000-00001.

    PubMed 4069324

  • Engelhardt M, Folkers W, Brenke C, Scholz M, Harders A, Fidorra H, Schmieder K. Neurosurgical operations with the patient in sitting position: analysis of risk factors using transcranial Doppler sonography. Br J Anaesth. 2006 Apr;96(4):467-72. doi: 10.1093/bja/ael015. Epub 2006 Feb 7.

    PubMed 16464980

  • Van Abel KM, Moore EJ. The rise of transoral robotic surgery in the head and neck: emerging applications. Expert Rev Anticancer Ther. 2012 Mar;12(3):373-80. doi: 10.1586/era.12.7.

    PubMed 22369328

  • Moore EJ, Olsen KD, Martin EJ. Concurrent neck dissection and transoral robotic surgery. Laryngoscope. 2011 Mar;121(3):541-4. doi: 10.1002/lary.21435. Epub 2011 Jan 4.

    PubMed 21344431

  • Weinstein GS, O'Malley BW Jr, Desai SC, Quon H. Transoral robotic surgery: does the ends justify the means? Curr Opin Otolaryngol Head Neck Surg. 2009 Apr;17(2):126-31. doi: 10.1097/MOO.0b013e32832924f5.

    PubMed 19342953

Questions about this trial

What is this clinical trial studying?

A study testing Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device in people with Oropharyngeal Neoplasms and Head and Neck Cancer, run by Mayo Clinic at 1 site in United States.

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 11 inclusion and 0 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

TORS surgery completion in the seated position (time frame: Measures assessed at time of intervention (during surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792322, which also lists 7 linked publications.

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 4 Jun 2025.

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