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Robotic scalpel takes on head and neck cancer

NCT ID NCT01473784

Disease control Sponsor: Ohio State University Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a less invasive robotic surgery called TORS for people with head and neck tumors. The goal is to see if it is safe and effective, with fewer side effects and faster recovery than traditional surgery. Up to 600 participants will be enrolled, and their outcomes like blood loss and recovery time will be tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transoral robotic surgery (TORS) using the da Vinci system
What this could lead to
If successful, this could make head and neck cancer surgery less invasive, with fewer side effects and quicker recovery.
What could go wrong
This is an early pilot study, so results are not yet proven. The surgery may not be suitable for all patients, and risks like bleeding or complications remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2007

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx) * Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation * Written informed consent and/or Consent waiver by institutional review board (IRB) Exclusion Criteria: * Unexplained fever and/or untreated, active infection * Patient pregnancy * Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm. * The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches * Inability to grant informed consent * INTRAOPERATIVE EXCLUSION CRITERIA: * Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally

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Conditions

The condition(s) this trial relates to.

carcinoma in situ of hypopharynx hypopharynx cancer laryngeal neoplasm larynx carcinoma in situ Mouth Neoplasms Squamous Cell Carcinoma of Head and Neck tongue cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent adenoid cystic carcinoma of the oral cavity Recurrent mucoepidermoid carcinoma of the oral cavity Recurrent squamous cell carcinoma of the hypopharynx Recurrent squamous cell carcinoma of the larynx Recurrent squamous cell carcinoma of the lip and oral cavity Recurrent verrucous carcinoma of the larynx Recurrent verrucous carcinoma of the oral cavity Stage 0 hypopharyngeal cancer Stage 0 laryngeal cancer Stage 0 lip and oral cavity cancer Stage I adenoid cystic carcinoma of the oral cavity Stage I mucoepidermoid carcinoma of the oral cavity Stage I squamous cell carcinoma of the hypopharynx Stage I squamous cell carcinoma of the larynx Stage I squamous cell carcinoma of the lip and oral cavity Stage I verrucous carcinoma of the larynx Stage I verrucous carcinoma of the oral cavity Stage II adenoid cystic carcinoma of the oral cavity Stage II mucoepidermoid carcinoma of the oral cavity Stage II squamous cell carcinoma of the hypopharynx Stage II squamous cell carcinoma of the larynx Stage II squamous cell carcinoma of the lip and oral cavity Stage II verrucous carcinoma of the larynx Stage II verrucous carcinoma of the oral cavity Stage III adenoid cystic carcinoma of the oral cavity Stage III mucoepidermoid carcinoma of the oral cavity Stage III squamous cell carcinoma of the hypopharynx Stage III squamous cell carcinoma of the larynx Stage III squamous cell carcinoma of the lip and oral cavity Stage III verrucous carcinoma of the larynx Stage III verrucous carcinoma of the oral cavity Stage IV squamous cell carcinoma of the hypopharynx Stage IVA adenoid cystic carcinoma of the oral cavity Stage IVA mucoepidermoid carcinoma of the oral cavity Stage IVA squamous cell carcinoma of the larynx Stage IVA squamous cell carcinoma of the lip and oral cavity Stage IVA verrucous carcinoma of the larynx Stage IVA verrucous carcinoma of the oral cavity Stage IVB adenoid cystic carcinoma of the oral cavity Stage IVB mucoepidermoid carcinoma of the oral cavity Stage IVB squamous cell carcinoma of the larynx Stage IVB squamous cell carcinoma of the lip and oral cavity Stage IVB verrucous carcinoma of the larynx Stage IVB verrucous carcinoma of the oral cavity Stage IVC adenoid cystic carcinoma of the oral cavity Stage IVC mucoepidermoid carcinoma of the oral cavity Stage IVC squamous cell carcinoma of the larynx Stage IVC squamous cell carcinoma of the lip and oral cavity Stage IVC verrucous carcinoma of the larynx Stage IVC verrucous carcinoma of the oral cavity Tongue cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

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