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Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

NCT03083106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-01-30

No results posted yet for this study

Summary

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

Conditions

  • Snoring

Interventions

DEVICE

Elevoplasty

The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting.

Sponsors & Collaborators

  • Zelegent, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter J. Catalano, MD · St. Elizabeth's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2017-09-29
Completion
2017-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083106 on ClinicalTrials.gov