Clinical trial NCT03049280: Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Official title: A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Performance
timeFrame: Intraoperative
measure: Number of Subjects With Device-related Serious Adverse Events
timeFrame: Intraoperative period
Secondary outcomes:
measure: Positive Surgical Margin
timeFrame: Through14-days postoperatively
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Board of Trustees of the Leland Stanford Junior University
state: California
city: Celebration
country: United States
facility: Florida Hospital
state: Florida
city: Philadelphia
country: United States
facility: Trustees of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Christopher Holsinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.