S.I.LE.N.C.E. Clinical Study for Elevoplasty®
The S.I.LE.N.C.E. Clinical Study is a multi-center clinical trial to evaluate the safety and efficacy of Snoring Intervention via Elevoplasty® in a Non-surgical Clinical Environment (S.I.LE.N.C.E.).
The principal investigator is Dr. Michael Friedman, Chairman of Otolaryngology – Head & Neck Surgery at Advocate Illinois Masonic Medical Center in Chicago, Professor of Otolaryngology at Rush University Medical Center, and Medical Director of ChicagoENT, a multi-physician private practice with locations in and around the greater Chicago, IL area.
Clinical Sites
The eight clinical sites to receive Investigational Review Board (IRB) approval to enroll patients are:
Clinical Center | Location | Began Enrolling Patients |
Staten Island University Hospital |
Staten Island, NY |
March 10, 2017 |
ChicagoENT |
Chicago, IL |
March 17, 2017 |
Medical University of South Carolina |
Charleston, SC |
March 22, 2017 |
ENTRUST Medical |
Orange, CA |
May 4, 2017 |
St. Elizabeth’s Medical Center |
Boston, MA |
June 2, 2017 |
Park Avenue Sinus & Sleep Center |
New York, NY |
July 14, 2017 |
University of Tennessee, Memphis |
Memphis, TN |
July 31, 2017 |
Tibor Rubin VA Medical Center |
Long Beach, CA |
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Clinical Investigators
The investigators in the S.I.LE.N.C.E. Clinical Study include both academic institutions and private practitioners, among them some of the foremost thought leaders in sleep disorder treatments and international lecturers on sleep surgery in the field of otolaryngology:
Michael Friedman, MD, FACS, Principal Investigator
Chairman of Otolaryngology – Head & Neck Surgery, Advocate Illinois Masonic Medical Center
Professor of Otolaryngology, Rush University Medical Center
M. Boyd Gillespie, MD, MSCR
Chief of Otolaryngology, University of Tennessee, Memphis
Principal Investigator in multiple clinical trials of implantable devices for snoring and OSA
Peter J. Catalano, MD, FACS, FARS
Chief of Otolaryngology, St. Elizabeth’s Medical Center / Tufts University School of Medicine
Faramarz A. Shabdiz, MD, FACS
St. Joseph Hospital, La Veta Surgical Center and Children’s Hospital of Orange County
Ted A. Meyer, MD, PhD
Director of Cochlear Implant Center, Medical University of South Carolina
David H. Hiltzik, MD
Staten Island University Hospital
Jeffrey Ahn, MD
Park Avenue Sinus & Sleep Center
Norman Ge, MD
Tibor Rubin VA Medical Center
Learn more about the S.I.LE.N.C.E. Clinical Investigators
Clinical Study Timeline
The study completed enrolling patients on September 2017, and the final follow-up data point was collected in April 2018. In total, 52 patients were treated with the Elevoplasty® procedure in the trial. They and their bed partners completed their six month study follow-up.
The results of this pivotal, multi-center trial supported a regulatory submission to the U.S. Food and Drug Administration (FDA) in April 2018. The FDA issued a 510(k) clearance for the Elevo kit in December 2018.