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The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Primary Purpose

Epiphora

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sinopsys Lacrimal Stent
Sponsored by
Sinopsys Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiphora focused on measuring Epiphora, Lacrimal Stent, Lacrimal System

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University of Colorado Health Sciences Center
  • Center for Sight
  • Eye Care Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sinopsys Lacrimal Stent

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline

Secondary Outcome Measures

Measurement of device insertion success
Evaluation of all safety
Recording of all safety events that occur in the first six months of treatment

Full Information

First Posted
September 11, 2014
Last Updated
February 11, 2016
Sponsor
Sinopsys Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT02240615
Brief Title
The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora
Official Title
The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinopsys Surgical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora
Keywords
Epiphora, Lacrimal Stent, Lacrimal System

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sinopsys Lacrimal Stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sinopsys Lacrimal Stent
Intervention Description
Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora
Primary Outcome Measure Information:
Title
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.
Description
PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline
Time Frame
Six Months
Secondary Outcome Measure Information:
Title
Measurement of device insertion success
Time Frame
Procedural
Title
Evaluation of all safety
Description
Recording of all safety events that occur in the first six months of treatment
Time Frame
Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Ross, MD
Organizational Affiliation
Sinopsys Surgical Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Teena Augostino
Organizational Affiliation
Sinopsys Surgical Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Center for Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States

12. IPD Sharing Statement

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The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

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