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Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS

NCT03066908 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-09-26

No results posted yet for this study

Summary

A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys® Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.

Conditions

  • Chronic Sinus Infection

Interventions

DEVICE

Sinopsys® Lacrimal Stent

Transcaruncular paranasal sinus or nasal cavity access for the purpose of irrigating the ethmoid sinus with saline

Sponsors & Collaborators

  • Sinopsys Surgical

    lead INDUSTRY

Principal Investigators

  • Joel Hale · Sinopsys Surgical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2024-10-31
Completion
2024-10-31
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 NCT03066908 on ClinicalTrials.gov