Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical SystemNCT02002845
A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
An observational study of Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System, run by Intuitive Surgical at 3 sites in United States.
Trial summary
A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
- What is being tested?
- robotic surgery using the da Vinci Surgical System
- Type of treatment
- Medical device
- How many people
- 285 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Feb 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
Who may be able to join
- The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure.
- Subject was ≥18 years of age at the time of procedure
Who cannot join
- Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy.
- Subject underwent a TORS procedure for oropharyngeal cancer
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Middlesex Hospital
Middletown, Connecticut, 06457
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Jose Mercey Health System
Ypsilanti, Michigan, 48197
About this study
A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.
Read the detailed description
Primary Effectiveness Endpoint:
- Ability to complete procedure without a need for conversion to a non-robotic approach
Safety Endpoint:
Assessment of adverse events through post-operative follow-up including but not limited to:
- Bleeding
▪ Mortality
Additional endpoints evaluated may include:
- Procedure times
- Length of hospital stay
- Volume of tissue resected
- Use of tissue sealants
- Conditions
- Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
- Being tested
- robotic surgery using the da Vinci Surgical System
- Keywords
- Tongue base resection, partial glossectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgery using the da Vinci Surgical SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Robotic arm | Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System Receives: Device: robotic surgery using the da Vinci Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Ability to complete procedure without a need for conversion to a non-robotic approach
Measured: intra-operative
Primary Safety endpoint
Assessment of adverse events through post-operative follow-up including but not limited to:
- Bleeding
▪ Mortality
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical SystemStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shilpa Mehendale, MS, Study director, Intutive Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002845
- Sponsor's protocol ID
- Non-Tumor based TORS procedure
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
- ClinicalTrials.gov ID
- NCT02002845
- Acronym / sponsor ID
- Non-Tumor based TORS procedure
- Conditions
- Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
- Keywords
- Tongue base resection, partial glossectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Dec 2013 (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.
A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.
Detailed description
Primary Effectiveness Endpoint:
- Ability to complete procedure without a need for conversion to a non-robotic approach
Safety Endpoint:
Assessment of adverse events through post-operative follow-up including but not limited to:
- Bleeding
▪ Mortality
Additional endpoints evaluated may include:
- Procedure times
- Length of hospital stay
- Volume of tissue resected
- Use of tissue sealants
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic arm | – | Device: robotic surgery using the da Vinci Surgical SystemPatient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
Key inclusion criteria (2 listed)
- The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure.
- Subject was ≥18 years of age at the time of procedure
Key exclusion criteria (2 listed)
- Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy.
- Subject underwent a TORS procedure for oropharyngeal cancer
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 |
|---|---|---|
| robotic surgery using the da Vinci Surgical System | Device | Robotic arm |
Primary outcome
Primary Effectiveness Endpoint
Time frame: intra-operative
Ability to complete procedure without a need for conversion to a non-robotic approach
Primary Safety endpoint
Time frame: up to 30 days after surgery
Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality
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 10 Dec 2015.
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.
Shilpa Mehendale, MS study director
Intutive Surgical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System, run by Intuitive Surgical at 3 sites 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 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Primary Effectiveness Endpoint (time frame: intra-operative). The study lists 2 primary outcomes in all. 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 10 Dec 2015.