NCT02240615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

September 11, 2014

Last Update Submit

February 11, 2016

Conditions

Epiphora

Keywords

EpiphoraLacrimal StentLacrimal System

Outcome Measures

Primary Outcomes (1)

  • 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

    Six Months

Secondary Outcomes (2)

  • Measurement of device insertion success

    Procedural

  • Evaluation of all safety

    Six Months

Study Arms (1)

Sinopsys Lacrimal Stent

EXPERIMENTAL

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

Interventions

Sinopsys Lacrimal StentDEVICE

Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

Sinopsys Lacrimal Stent

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active infection
  • Craniofacial deformity
  • Severe inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Center for Sight

Sarasota, Florida, 34239, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Harry Ross, MD

    Sinopsys Surgical Inc.

    STUDY DIRECTOR

  • Teena Augostino

    Sinopsys Surgical Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 15, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

US(4)