Trial Outcomes & Findings for Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study (NCT NCT03049280)

NCT ID: NCT03049280

Last Updated: 2020-10-06

Results Overview

Performance defined as the conversion to an open approach required to complete the procedure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2020-10-06

Participant Flow

Recruitment of study subjects occurred between April 2017 and October 2017 at 3 participating sites

Participant milestones

Measure	TORS Subjects that underwent transoral otolaryngology robotic surgery
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	TORS Subjects that underwent transoral otolaryngology robotic surgery
Overall Study Physician Decision	1

Baseline Characteristics

Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study

Baseline characteristics by cohort

Measure	TORS n=33 Participants Subjects that underwent transoral otolaryngology robotic surgery
Age, Continuous	61.8 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: all subjects that were eligible to participate and underwent TORS

Performance defined as the conversion to an open approach required to complete the procedure

Outcome measures

Measure	TORS n=33 Participants subjects undergoing transoral otolaryngology robotic surgery
Performance	0 Participants

PRIMARY outcome

Timeframe: Intraoperative period

Population: Subject that were eligible to participate and underwent TORS

Safety is determined by measuring the number of subjects that experience device-related serious adverse events

Outcome measures

Measure	TORS n=33 Participants subjects undergoing transoral otolaryngology robotic surgery
Number of Subjects With Device-related Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Through14-days postoperatively

Rate of final positive surgical margins confirmed by pathology

Outcome measures

Measure	TORS n=33 Participants subjects undergoing transoral otolaryngology robotic surgery
Positive Surgical Margin	1 Participants

Adverse Events

TORS

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	TORS n=33 participants at risk Subjects that underwent transoral otolaryngology robotic surgery
General disorders Hypoxemia	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
Vascular disorders Left middle cerebral artery (MCA) stroke	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
Blood and lymphatic system disorders Hemorrhage	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
Respiratory, thoracic and mediastinal disorders Pneumonia	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
Gastrointestinal disorders clostridium difficile enterocolitis	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up

Other adverse events

Measure	TORS n=33 participants at risk Subjects that underwent transoral otolaryngology robotic surgery
Skin and subcutaneous tissue disorders Neck seroma	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
General disorders Nasal regurgitation	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
Social circumstances Fall	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up
General disorders Trismus	3.0% 1/33 • Number of events 1 • Adverse events were collected during the conduct of the study and through 7 weeks follow-up

Additional Information

Intuitive Surgical Clinical Affairs

Intuitive Surgical

Phone: 408-523-2100

Email: sylvie.akiel-fu@intusurg.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place