Oropharyngeal Cancer
Conditions
Brief summary
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
Detailed description
A prospective, multicenter investigation to evaluate the safety and clinical performance of the da Vinci SP Surgical System, instruments, and accessories in TORS procedures for malignant oropharyngeal tumors classified as T1 and T2.
Interventions
Transoral robotic surgery for T1 & T2 oropharyngeal cancers
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance | Intraoperative | Performance defined as the conversion to an open approach required to complete the procedure |
| Number of Subjects With Device-related Serious Adverse Events | Intraoperative period | Safety is determined by measuring the number of subjects that experience device-related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Surgical Margin | Through14-days postoperatively | Rate of final positive surgical margins confirmed by pathology |
Countries
United States
Participant flow
Recruitment details
Recruitment of study subjects occurred between April 2017 and October 2017 at 3 participating sites
Participants by arm
| Arm | Count |
|---|---|
| TORS Subjects that underwent transoral otolaryngology robotic surgery | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | TORS |
|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 33 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 4 / 33 |
| serious Total, serious adverse events | 4 / 33 |
Outcome results
Primary
Number of Subjects With Device-related Serious Adverse Events
Safety is determined by measuring the number of subjects that experience device-related serious adverse events
Time frame: Intraoperative period
Population: Subject that were eligible to participate and underwent TORS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TORS | Number of Subjects With Device-related Serious Adverse Events | 0 Participants |
Primary
Performance
Performance defined as the conversion to an open approach required to complete the procedure
Time frame: Intraoperative
Population: all subjects that were eligible to participate and underwent TORS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TORS | Performance | 0 Participants |
Secondary
Positive Surgical Margin
Rate of final positive surgical margins confirmed by pathology
Time frame: Through14-days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TORS | Positive Surgical Margin | 1 Participants |