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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2017-12-26

Brief Summary

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

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Detailed Description

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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.

Conditions

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Oropharyngeal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transoral robotic surgery

Group Type EXPERIMENTAL

Transoral robotic surgery

Intervention Type DEVICE

Transoral robotic surgery for T1 \& T2 oropharyngeal cancers

Interventions

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Transoral robotic surgery

Transoral robotic surgery for T1 \& T2 oropharyngeal cancers

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No