N/A
N=33
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Oropharyngeal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03049280 ↗Enrolled (actual)
33
Serious AEs
12.1%
Results posted
Aug 2020
Primary outcome: Primary: Performance — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transoral robotic surgery (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intuitive Surgical
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance |
— | — |
| PRIMARY Number of Subjects With Device-related Serious Adverse Events |
— | — |
| SECONDARY Positive Surgical Margin |
1 | — |
Summary
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- T1 or T2 malignant oropharyngeal tumor
- Tumor amenable to transoral resection
- No previous treatment for the index tumor
- Willing and able to provide written informed consent
- Willing and able to comply with the study protocol requirements
Exclusion Criteria
- T3 or T4 stage tumor
- Previous radiation treatment to the head and neck, with or without chemotherapy
- Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers
- Pre-operative expectation of needing microvascular soft-tissue reconstruction
- Tumor that invades and/or abuts the internal and/or external carotid artery
- Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer
- Evidence of mandibular invasion of tumor
- Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2
- On a medication that interferes with clotting that cannot be stopped prior to surgery
- Contraindication for general anesthesia or surgery
- Mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Pregnant or suspected to be pregnant
Data sourced from ClinicalTrials.gov (NCT03049280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.