Transoral Robotic Surgery (TORS) for Sleep Apnea
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
The purpose of this study is to assess if the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) allows for "adequate exposure" for transoral resection of hypertrophic lingual tonsils in patients with obstructive sleep apnea.
Key facts
- Study ID
- NCT01187160
- Run by
- University of Pennsylvania
- People needed
- 154
- Starts
- 2009-10-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-08-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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