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

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Intuitive Surgical

Status

Completed

Conditions

Oropharyngeal Cancer

Treatments

Device: Transoral robotic surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT03049280
ISI dV SP-TORS - 01

Details and patient eligibility

About

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

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Transoral robotic surgery
Experimental group
Treatment:
Device: Transoral robotic surgery

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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