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

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)

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33 participants in 1 patient group

Transoral robotic surgery

Experimental group

Treatment:

Device: Transoral robotic surgery