A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
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|ClinicalTrials.gov Identifier: NCT00627562|
Recruitment Status : Unknown
Verified March 2016 by Richard V. Smith, MD, Montefiore Medical Center.
Recruitment status was: Active, not recruiting
First Posted : March 3, 2008
Last Update Posted : March 17, 2016
- 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.
5. Endpoints will be compared to historical controls.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2017|
robot assisted endoscopic head and neck surgery
Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System
Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System
- ability to adequately visualize the operative field and complete planned surgery [ Time Frame: 1 day ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627562
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Study Chair:||Richard V Smith, MD||Montefiore Medical Center|