Head and Neck NeoplasmsTORSNCT01059357
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
A study testing Da Vinci Robotic Transoral Robotic Surgical System in people with Head and Neck Neoplasms, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Da Vinci Robotic Transoral Robotic Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
Who cannot join
- Unexplained fever and/or untreated, active infection
- Patient pregnancy
- Previous head and neck surgery precluding transoral/robotic procedures
- The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Read the detailed description
Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).
- Conditions
- Head and Neck Neoplasms
- Being tested
- Da Vinci Robotic Transoral Robotic Surgical System
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci Robotic Transoral Robotic Surgical SystemDevice
Also called (TORS) Da Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Transoral Robotic Surgery (TORS) | Experimental | Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Receives: Device: Da Vinci Robotic Transoral Robotic Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis
Measured: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
Secondary outcomes (5)
Operative Time
The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.
Measured: At time of surgery, up to 3 hours
Number of Participants With Blood Loss and Complications
Measured: 6 months
Average Time to Set up and Perform Procedures
This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.
Measured: At time of surgery, up to 3 hours
Number of Correctly Predicted Success of TORS Preoperatively
This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
Measured: preoperative
QOL
Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua D. Waltonen, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059357
- Sponsor's protocol ID
- IRB00009802
- Other IDs
- CCCWFU 60209
- Acronym
- TORS
- Status last verified
- Nov 2018
- First submitted
- 21 Jan 2010
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
- ClinicalTrials.gov ID
- NCT01059357
- Acronym / sponsor ID
- TORS / IRB00009802
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Detailed description
Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral Robotic Surgery (TORS) | Experimental | Device: Da Vinci Robotic Transoral Robotic Surgical SystemTransoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
Key exclusion criteria (4 listed)
- Unexplained fever and/or untreated, active infection
- Patient pregnancy
- Previous head and neck surgery precluding transoral/robotic procedures
- The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Da Vinci Robotic Transoral Robotic Surgical SystemAlso: (TORS) Da Vinci Robotic Transoral Robotic Surgical System(TORS) Da Vinci Robotic Transoral Robotic Surgical System | Device | Transoral Robotic Surgery (TORS) |
Primary outcome
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
Time frame: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis
5 secondary outcomes
Operative Time
Time frame: At time of surgery, up to 3 hours
Number of Participants With Blood Loss and Complications
Time frame: 6 months
Average Time to Set up and Perform Procedures
Time frame: At time of surgery, up to 3 hours
Number of Correctly Predicted Success of TORS Preoperatively
Time frame: preoperative
QOL
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joshua D. Waltonen, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Da Vinci Robotic Transoral Robotic Surgical System in people with Head and Neck Neoplasms, run by Wake Forest University Health Sciences 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 2 inclusion and 4 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 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. (time frame: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months). 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 Nov 2018.