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

Not Applicable

Completed

• Conditions: Oropharyngeal Cancer
• Interventions: Device: Transoral robotic surgery

• Registration Number: NCT03049280
• Lead Sponsor: Intuitive Surgical

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.

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-10
• Study Start: 2017-04-17
• Primary Completion: 2017-11-14
• Study Completion: 2017-12-26
• Results First Submitted: 2020-07-28
• Results First Submitted QC: 2020-07-28
• Results First Posted: 2020-08-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transoral robotic surgery	Transoral robotic surgery	-

Primary Outcome Measures

Name	Time	Method
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
Performance	Intraoperative	Performance defined as the conversion to an open approach required to complete the procedure

Secondary Outcome Measures

Name	Time	Method
Positive Surgical Margin	Through14-days postoperatively	Rate of final positive surgical margins confirmed by pathology

Trial Locations

Locations (3)

Board of Trustees of the Leland Stanford Junior University; 🇺🇸 Palo Alto, California, United States

Florida Hospital; 🇺🇸 Celebration, Florida, United States

Trustees of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States