Status:
COMPLETED
Transoral Robotic Surgery (TORS) for Sleep Apnea
Lead Sponsor:
University of Pennsylvania
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Visit 1 - Outpatient Clinical Setting. The patient will be evaluated prior to treatment in the outpatient clinical setting in a way which is consistent for routine workup prior to any surgery of the t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01187160
Start Date
October 1 2009
End Date
November 1 2014
Last Update
August 22 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104