Trial Outcomes & Findings for Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract (NCT NCT00721539)

Results Overview

Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Six weeks

Results posted on

2016-11-03

Participant Flow

Patients recruited through tertiary care medical center specializing in head and neck cancer; enrollment dates 9/2010 to 9/2012.

Exclusion criteria include unexplained fever, active infection, pregnancy, anatomic parameters which preclude surgery including trismus, limited range of neck motion, poor dentition, and physical features such as redundant hypopharyngeal tissues which prevent adequate exposure of tumor.

Participant milestones

Participant milestones
Measure	Transoral Robotic Surgery Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transoral Robotic Surgery n=9 Participants Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	41.5 Years n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Six weeks

Population: Subjects enrolled in this pilot study.

Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery n=9 Participants Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
Overall Complication Rate (Intraoperative and Postoperative)	0 Participants

SECONDARY outcome

Timeframe: Six weeks

Population: Adult patients 18 years of age and over

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery n=9 Participants Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure	9 Participants

SECONDARY outcome

Timeframe: Duration of procedure up to two hours

Population: Participants

Blood lost during procedure

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery n=9 Participants Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
Average Blood Loss	50 mL Interval 0.0 to 150.0

SECONDARY outcome

Timeframe: Up to four hours (240 minutes)

Population: Participants

Average operative time in minutes

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery n=9 Participants Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
Average Operative Time	112 Minutes Interval 38.0 to 208.0

Adverse Events

Transoral Robotic Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward Damrose, MD, associate professor

Stanford

Phone: 650-725-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place