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

Oropharyngeal Cancer Clinical Trial

Official title:

A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049280
• Other study ID #: ISI dV SP-TORS - 01
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: December 26, 2017

Study information

• Verified date: September 2020
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 26, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Device:
• Transoral robotic surgery
Transoral robotic surgery for T1 & T2 oropharyngeal cancers

Locations

Country	Name	City	State
United States	Florida Hospital	Celebration	Florida
United States	Board of Trustees of the Leland Stanford Junior University	Palo Alto	California
United States	Trustees of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance	Performance defined as the conversion to an open approach required to complete the procedure	Intraoperative
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	Intraoperative period
Secondary	Positive Surgical Margin	Rate of final positive surgical margins confirmed by pathology	Through14-days postoperatively