Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01254734
Eligibility Criteria:
Inclusion Criteria:
* Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
* Surgical access is amenable to treatment with conventional transoral surgical procedures
* ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
* Patients should have no serious acute infection
* Patients must sign a study-specific informed consent form
Exclusion Criteria:
* Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
* ASA score \> 4; ECOG PS score \> 3
* Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
* The presence of medical conditions which contraindicate general anesthesia
* Unexplained fever or untreated, active infection
* Inability to obtain exposure to allow performance of the planned transoral surgical procedure
* Proposed surgical site with history of prior treatment: radiation
* Tumor adherent to carotid artery or jugular vein
* Fixation to pre-vertebral tumor
* Mandibular invasion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01254734
Study Brief:
Protocol Section:
NCT01254734