Head and Neck NeoplasmsNCT00627562
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
A study testing robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System in people with Head and Neck Neoplasms, run by Montefiore Medical Center at 1 site in United States.
Trial summary
1. Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques. 2. They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.). 3. 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?
- robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years f age
- Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck
- Written informed consent
Who cannot join
- Unexplained fever and/or untreated, active infection
- Pregnancy
- Previous head and neck surgery precluding transoral/endoscopic/robotic procedures
- Presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
- Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques.
- They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.).
- The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate.
- Secondary objective include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy.
- To evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery.
- Endpoints will be compared to historical controls.
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).22 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System
- Keywords
- robotic, robot assisted, minimally invasive, tumors of head and neck
- 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.
robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical SystemDevice
Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | robot assisted endoscopic head and neck surgery Receives: Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ability to adequately visualize the operative field and complete planned surgery
Measured: 1 day
Secondary outcomes (6)
complication rate compared to standard endoscopic and minimally invasive procedures
Measured: 1 month
blood loss compared to historical controls of endoscopic and minimally invasive procedures
Measured: 1 day
quality of life at early (1-3 months) and late (one year)
Measured: 1 year
number of days hospitalized immediately after surgery
Measured: at discharge from hospital
Time to recurrence of tumor or other pathology for which procedure was performed
Measured: at recurrence of tumor or pathology
Time from start of treatment to death
Measured: at time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2014
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard V. Smith, MD, Montefiore Medical Center
- Investigators
- Richard V Smith, MD, Study chair, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627562
- Sponsor's protocol ID
- 07-03-080
- Status last verified
- Mar 2016
- First submitted
- 5 Feb 2008
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gourin CG, Terris DJ. Surgical robotics in otolaryngology: expanding the technology envelope. Curr Opin Otolaryngol Head Neck Surg. 2004 Jun;12(3):204-8. doi: 10.1097/01.moo.0000122309.13359.af.
PubMed 15167030Hockstein NG, Nolan JP, O'Malley BW Jr, Woo YJ. Robot-assisted pharyngeal and laryngeal microsurgery: results of robotic cadaver dissections. Laryngoscope. 2005 Jun;115(6):1003-8. doi: 10.1212/01.WNL.0000164714.90354.7D.
PubMed 15933510Hockstein NG, O'Malley BW Jr, Weinstein GS. Assessment of intraoperative safety in transoral robotic surgery. Laryngoscope. 2006 Feb;116(2):165-8. doi: 10.1097/01.mlg.0000199899.00479.75.
PubMed 16467698Lobe TE, Wright SK, Irish MS. Novel uses of surgical robotics in head and neck surgery. J Laparoendosc Adv Surg Tech A. 2005 Dec;15(6):647-52. doi: 10.1089/lap.2005.15.647.
PubMed 16366877Tanna N, Joshi AS, Glade RS, Zalkind D, Sadeghi N. Da Vinci robot-assisted endocrine surgery: novel applications in otolaryngology. Otolaryngol Head Neck Surg. 2006 Oct;135(4):633-5. doi: 10.1016/j.otohns.2006.07.003. No abstract available.
PubMed 17011430
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT00627562
- Acronym / sponsor ID
- 07-03-080
- Conditions
- Head and Neck Neoplasms
- Keywords
- robotic, robot assisted, minimally invasive, tumors of head and neck
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Mar 2008 (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.
- Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques.
- They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.).
- The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate.
- Secondary objective include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy.
- To evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery.
- Endpoints will be compared to historical controls.
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).22 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical Systemrobot assisted endoscopic head and neck surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years f age
- Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck
- Written informed consent
Key exclusion criteria (4 listed)
- Unexplained fever and/or untreated, active infection
- Pregnancy
- Previous head and neck surgery precluding transoral/endoscopic/robotic procedures
- 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 |
|---|---|---|
| robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical SystemPlanned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System | Device | 1 |
Primary outcome
ability to adequately visualize the operative field and complete planned surgery
Time frame: 1 day
6 secondary outcomes
complication rate compared to standard endoscopic and minimally invasive procedures
Time frame: 1 month
blood loss compared to historical controls of endoscopic and minimally invasive procedures
Time frame: 1 day
quality of life at early (1-3 months) and late (one year)
Time frame: 1 year
number of days hospitalized immediately after surgery
Time frame: at discharge from hospital
Time to recurrence of tumor or other pathology for which procedure was performed
Time frame: at recurrence of tumor or pathology
Time from start of treatment to death
Time frame: at time of death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Background: PubMed 15167030Gourin CG, Terris DJ. Surgical robotics in otolaryngology: expanding the technology envelope. Curr Opin Otolaryngol Head Neck Surg. 2004 Jun;12(3):204-8. doi: 10.1097/01.moo.0000122309.13359.af.
- Background: PubMed 15933510Hockstein NG, Nolan JP, O'Malley BW Jr, Woo YJ. Robot-assisted pharyngeal and laryngeal microsurgery: results of robotic cadaver dissections. Laryngoscope. 2005 Jun;115(6):1003-8. doi: 10.1212/01.WNL.0000164714.90354.7D.
- Background: PubMed 16467698Hockstein NG, O'Malley BW Jr, Weinstein GS. Assessment of intraoperative safety in transoral robotic surgery. Laryngoscope. 2006 Feb;116(2):165-8. doi: 10.1097/01.mlg.0000199899.00479.75.
- Background: PubMed 16366877Lobe TE, Wright SK, Irish MS. Novel uses of surgical robotics in head and neck surgery. J Laparoendosc Adv Surg Tech A. 2005 Dec;15(6):647-52. doi: 10.1089/lap.2005.15.647.
- Background: PubMed 17011430Tanna N, Joshi AS, Glade RS, Zalkind D, Sadeghi N. Da Vinci robot-assisted endocrine surgery: novel applications in otolaryngology. Otolaryngol Head Neck Surg. 2006 Oct;135(4):633-5. doi: 10.1016/j.otohns.2006.07.003. No abstract available.
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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.
Richard V Smith, MD study chair
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System in people with Head and Neck Neoplasms, run by Montefiore Medical Center 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 3 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: status not confirmed, as of the sponsor's last update on 17 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 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?
Results are not available in the source record.
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?
ability to adequately visualize the operative field and complete planned surgery (time frame: 1 day). 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 NCT00627562, which also lists 5 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 17 Mar 2016.