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Procedure

Robotic Surgery for Head and Neck Cancer

N/A

Recruiting

Led By Enver Ozer, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Be older than 18 years old

Must not have

INTRAOPERATIVE EXCLUSION CRITERIA: Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally

The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to eight years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying TORS, a less invasive type of surgery for head and neck cancer that may have fewer side effects and improve recovery.

Who is the study for?

This trial is for patients with benign or malignant tumors in the mouth or throat area who need diagnostic or therapeutic procedures. They must be able to have their oral cavity and throat accessed transorally for robotic surgery, and provide informed consent. Pregnant individuals, those with unexplained fevers, active infections, previous surgeries that interfere with this procedure, conditions contraindicating general anesthesia or transoral surgery are excluded.

What is being tested?

The study is examining the effectiveness of Transoral Robotic Surgery (TORS) on patients with head and neck tumors. TORS is a less invasive surgical method which may reduce side effects and improve recovery compared to traditional surgeries.

What are the potential side effects?

While TORS aims to minimize side effects by being less invasive than conventional surgery, potential risks could include bleeding, infection at the surgical site, pain or discomfort from the procedure, swelling, difficulty swallowing temporarily after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My mouth and throat area can be easily accessed for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Doctors can't see inside my body well enough to do surgery through my mouth.

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I cannot have general anesthesia or certain throat surgeries due to my health conditions.

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I have a fever or an active infection that hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to eight years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to eight years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to eight years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transoral robotic surgery (TORS)Experimental Treatment2 Interventions

Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

quality of life assessment

2006

Completed Phase 3

~940

transoral robotic surgery

2009

Completed Phase 1

~90

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

340 Previous Clinical Trials

293,895 Total Patients Enrolled

Enver Ozer, MD5.07 ReviewsPrincipal Investigator - Ohio State University

Ohio State University Comprehensive Cancer Center

1 Previous Clinical Trials

11 Total Patients Enrolled

5Patient Review

I had a great experience with both the physician and nursing staff. They were very informative and answered all of my questions. I would definitely recommend them to anyone.