A Pilot Study Assessing Surgical Exposure During Transoral Robotic Surgery (TORS) for Sleep Apnea Using the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA)
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Obstructive Sleep Apnea |
| Purpose: |
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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.
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| Study Summary: |
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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 tongue base for sleep apnea. This will include sleep nasendoscopy (see
below), and if it is predicted pre-treatment that the transoral robotic approach may be
appropriate then the patient will be given the option of participating in the study. This
will include a review of the patient's pre-operative sleep study and a
nasopharyngolaryngoscopic exam to assess for lingual tonsillar hypertrophy. A pre-operative
MRI will be obtained to provide quantitative measurement of the patient's tongue base
hypertrophy.
Visit 2 - Sleep Nasendoscopy. The patient will undergo sleep nasendoscopy as outlined below,
in order to assess the involvement of the tongue base in the patient's sleep disordered
breathing. This is a routine diagnostic procedure. Patients are pharmacologically induced
into a light phase of sleep and the upper airway is visualized directly with a
nasopharyngolaryngoscope. Anesthetic management will be performed in standard fashion, using
propofol titrated to an endpoint of moderate sedation, as is typically done for procedural
sedation in esophagogastroduodenoscopy. Administration will be logged to permit analysis of
dosing requirements. Respiratory pattern will be monitored noninvasively and logged to
permit correlation of obstruction to propofol administration.
Visit 3 - Intraoperative Setting. The patient will undergo an evaluation for "adequate
exposure" for transoral robotic surgery and if "adequate exposure" is achieved then they
will undergo transoral robotic surgery for lingual tonsillar hypertrophy to treat
obstructive sleep apnea.
Visit 4 - Postoperative Setting. This will be in the inpatient and/or outpatient setting
within three weeks of surgical procedure. The patient will undergo routine postoperative
clinical evaluation.
Visit 5 - Postoperative Testing. The patient will undergo a follow-up sleep study to
determine efficacy of the surgical procedure at three months post-operatively, the standard
interval used to determine the outcome of the procedure.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01187160 |
| Primary Contact: |
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Principal Investigator
Erica Thaler, M.D.
University of Pennsylvania
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Vince Gangemi, M.S.
Email: vince.c.gangemi@uphs.upenn.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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