Status:
WITHDRAWN
Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery
Lead Sponsor:
ArthroCare Corporation
Collaborating Sponsors:
Mayo Clinic
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative p...
Detailed Description
This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using the study device to treat OSA symptoms in an adult population is associated with less postoperative...
Eligibility Criteria
Inclusion
- Subject is \> or = 18 years of age
- Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
- Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
- Subject signs IRB-approved informed consent form
- Subject is willing and able to complete required follow-up.
Exclusion
- Subject has had a previous tonsillectomy
- Subject's RDI \>40
- Subject has a history of chronic use of narcotic pain medications
- Subject is unable to take liquid opioid analgesics
- Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00380458
Last Update
August 26 2015
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905