The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

February 11, 2016 updated by: Sinopsys Surgical

The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora

Prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Up to 10 patients will be enrolled and followed for six months. The primary objective is to demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular pathologies in this patient population. The primary outcome measure for performance is the relief of epiphora determined by both investigator assessment of stent patency and patient self-assessment of epiphora symptom improvement compared to baseline.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center
    • Florida
      • Sarasota, Florida, United States, 34239
        • Center For Sight
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically significant functional epiphora for at least three months
  • Keros classification 1 or 2 skull base anatomy

Exclusion Criteria:

  • Active infection
  • Craniofacial deformity
  • Severe inflammatory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sinopsys Lacrimal Stent
All enrolled patients will receive a Sinopsys Lacrimal Stent inserted from the caruncle to the ethmoid sinus. Discharge instructions will include administration of sterile saline and ophthalmic drops as well as assessments for device patency.
Device: Sinopsys Lacrimal Stent
Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of epiphora, determined by both 1) the Investigator assessment of the patency/function of the Sinopsys Lacrimal Stent ( and 2) the subject's self-assessment of tearing.
Time Frame: Six Months
PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline
Six Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of device insertion success
Time Frame: Procedural
Procedural
Evaluation of all safety
Time Frame: Six Months
Recording of all safety events that occur in the first six months of treatment
Six Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinopsys Surgical

Investigators

  • Study Director: Harry Ross, MD, Sinopsys Surgical Inc.
  • Study Director: Teena Augostino, Sinopsys Surgical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLS-US-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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