Clinical trial · Interventional
Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract
A Pilot Study Assessing Transoral Robotic Surgery (TORS) For Oral And Laryngopharyngeal Benign And Malignant Lesions Using The da Vinci® Robotic Surgical System
NCT00721539CI-TRIAL-00024709terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx.
Conditions
Conditions (3)
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 Cancers | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hypopharyngeal Neoplasms | Hypopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci Surgical Robot Platform | Device | — | UNRESOLVED |
| Transoral Robotic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Transoral Robotic Surgery
- description
- Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
- interventionNames
- Device: da Vinci Surgical Robot Platform
- Procedure: Transoral Robotic Surgery
Primary outcomes (1)
- measure
- Overall Complication Rate (Intraoperative and Postoperative)
- timeFrame
- Six weeks
- description
- Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.
Secondary outcomes (3)
- measure
- Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient or volunteer is 18 years of age or older * Patients must have indication for diagnosis and/or therapy of diseases of the oropharynx, hypopharynx, and/or larynx. Exclusion Criteria: * unexplained fever and/or untreated * active infection * pregnancy * anatomic parameters which preclude transoral surgery, such as: 1. trismus 2. limited range of neck motion 3. poor dentition 4. redundant hypopharyngeal or supraglottic tissue which would prevent adequate visualization of the tumor * participation in a research protocol which precludes participation in other protocols
References
Publications (0)
Data not yet available
No reference posted for this study.