The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02240615

Enrollment

Registered

2014-09-15

Start date

2014-10-31

Completion date

2016-02-29

Last updated

2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiphora

Keywords

Epiphora, Lacrimal Stent, Lacrimal System

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.

Interventions

DEVICESinopsys Lacrimal Stent

Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.	Six Months	PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026