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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to eight years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.

Secondary outcome measures

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

Assess the quality of life of the patients with TORS.

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

~10

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

289,807 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.

Media Library

Transoral Robotic Surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01473784 — N/A

Squamous Cell Carcinoma Research Study Groups: Transoral robotic surgery (TORS)

Squamous Cell Carcinoma Clinical Trial 2023: Transoral Robotic Surgery Highlights & Side Effects. Trial Name: NCT01473784 — N/A

Transoral Robotic Surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01473784 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available openings for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is actively enrolling participants after being first posted on December 3rd 2007 and edited as recently as October 28th 2022. The trial has the capacity to take in 360 patients at one site."

Answered by AI

What is the aggregate amount of individuals taking part in this research?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, initially posted on December 3rd 2007, is actively enrolling participants. A total of 360 patients are needed to be recruited at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

Enver Ozer 2007. "Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01473784.

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