Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Study Details
Study Description
Brief Summary
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transoral robotic surgery
|
Device: Transoral robotic surgery
Transoral robotic surgery for T1 & T2 oropharyngeal cancers
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Positive Surgical Margin [Through14-days postoperatively]
Rate of final positive surgical margins confirmed by pathology
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Board of Trustees of the Leland Stanford Junior University | Palo Alto | California | United States | 94304 |
| 2 | Florida Hospital | Celebration | Florida | United States | 34747 |
| 3 | Trustees of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
- Principal Investigator: Christopher Holsinger, MD, Stanford University
Study Documents (Full-Text)
More Information
Publications
None provided.- ISI dV SP-TORS - 01
Study Results
Participant Flow
| Recruitment Details | Recruitment of study subjects occurred between April 2017 and October 2017 at 3 participating sites |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TORS |
|---|---|
| Arm/Group Description | Subjects that underwent transoral otolaryngology robotic surgery |
| Period Title: Overall Study | |
| STARTED | 33 |
| COMPLETED | 32 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | TORS |
|---|---|
| Arm/Group Description | Subjects that underwent transoral otolaryngology robotic surgery |
| Overall Participants | 33 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
61.8
(7.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
15.2%
|
| Male |
28
84.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
4
12.1%
|
| Not Hispanic or Latino |
28
84.8%
|
| Unknown or Not Reported |
1
3%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
3%
|
| White |
30
90.9%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
6.1%
|
| Region of Enrollment (Count of Participants) | |
| United States |
33
100%
|
Outcome Measures
| Title | Performance |
|---|---|
| Description | Performance defined as the conversion to an open approach required to complete the procedure |
| Time Frame | Intraoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| all subjects that were eligible to participate and underwent TORS |
| Arm/Group Title | TORS |
|---|---|
| Arm/Group Description | subjects undergoing transoral otolaryngology robotic surgery |
| Measure Participants | 33 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Subjects With Device-related Serious Adverse Events |
|---|---|
| Description | Safety is determined by measuring the number of subjects that experience device-related serious adverse events |
| Time Frame | Intraoperative period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subject that were eligible to participate and underwent TORS |
| Arm/Group Title | TORS |
|---|---|
| Arm/Group Description | Subjects that underwent transoral otolaryngology robotic surgery |
| Measure Participants | 33 |
| Count of Participants [Participants] |
0
0%
|
| Title | Positive Surgical Margin |
|---|---|
| Description | Rate of final positive surgical margins confirmed by pathology |
| Time Frame | Through14-days postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TORS |
|---|---|
| Arm/Group Description | Subject undergoing transoral otolaryngology robotic surgery |
| Measure Participants | 33 |
| Count of Participants [Participants] |
1
3%
|
Adverse Events
| Time Frame | Adverse events were collected during the conduct of the study and through 7 weeks follow-up | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | TORS | |
| Arm/Group Description | Subjects that underwent transoral otolaryngology robotic surgery | |
All Cause Mortality |
||
| TORS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | |
Serious Adverse Events |
||
| TORS | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/33 (12.1%) | |
| Blood and lymphatic system disorders | ||
| Hemorrhage | 1/33 (3%) | 1 |
| Gastrointestinal disorders | ||
| clostridium difficile enterocolitis | 1/33 (3%) | 1 |
| General disorders | ||
| Hypoxemia | 1/33 (3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumonia | 1/33 (3%) | 1 |
| Vascular disorders | ||
| Left middle cerebral artery (MCA) stroke | 1/33 (3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| TORS | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/33 (12.1%) | |
| General disorders | ||
| Nasal regurgitation | 1/33 (3%) | 1 |
| Trismus | 1/33 (3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Neck seroma | 1/33 (3%) | 1 |
| Social circumstances | ||
| Fall | 1/33 (3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Intuitive Surgical Clinical Affairs |
|---|---|
| Organization | Intuitive Surgical |
| Phone | 408-523-2100 |
| sylvie.akiel-fu@intusurg.com |
- ISI dV SP-TORS - 01