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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01187160
Eligibility Criteria:
Inclusion Criteria:
* Patient is 18 or older at time of treatment.
* Patient must present with indications for surgical management of the tongue base to treat obstructive sleep apnea.
* Written informed consent and/or consent waiver by IRB.
Exclusion Criteria:
* Pre-operative exclusion criteria:
* Unexplained fever and/or untreated, active infection.
* Patient pregnancy.
* Previous head and neck surgery precluding transoral/robotic procedures.
* The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches.
* Intra-operative exclusion criteria (It is recognized that sometimes patients cannot be excluded from study participation until prepared in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting):
* Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01187160
Study Brief:
Protocol Section:
NCT01187160