Clinical trial · Interventional
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate. 4. 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. 5. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- robot assisted endoscopic head and neck surgery
- interventionNames
- Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System
Primary outcomes (1)
- measure
- ability to adequately visualize the operative field and complete planned surgery
- timeFrame
- 1 day
Secondary outcomes (6)
- measure
- complication rate compared to standard endoscopic and minimally invasive procedures
- timeFrame
- 1 month
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (5)
- BACKGROUNDGourin 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. PMID 15167030
- BACKGROUNDHockstein 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. PMID 15933510
- BACKGROUNDHockstein 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. PMID 16467698
- BACKGROUNDLobe 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. PMID 16366877
- BACKGROUNDTanna 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. PMID 17011430