S.I.LE.N.C.E. Clinical Study

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 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 29, 2017. In total, 52 patients were treated with the Elevoplasty™ procedure in the trial. They and their bed partners are completing or have completed their six month study follow-up.

Zelegent expects that the final data point in the study will be collected in April 2018.

If the clinical results of this pivotal, multi-center trial are consistent with the results obtained in the single-center pilot trial performed in New York in 2015, the data will support a regulatory submission to the U.S. Food and Drug Administration (FDA) in 2018.

Note: Elevoplasty™ is an investigational procedure and the Elevo™ Kit Snoring Intervention Device is an investigational device only — not for sale in the U.S.

If you are interested in the possibility of enrolling in a future clinical trial involving Elevoplasty™, please fill out the form.