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LATERA-OFFICE Study

NCT02964312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2020-09-03

Study results available
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Summary

Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without concurrent turbinate reduction procedures in an office setting.

Conditions

  • Nasal Obstruction

Interventions

DEVICE

Nasal Implant

Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.

Sponsors & Collaborators

  • New Arch Consulting

    collaborator INDUSTRY

  • Spirox, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Sidle, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2018-03-21
Completion
2019-08-29
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 NCT02964312 on ClinicalTrials.gov