The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Early Phase 1

Completed

• Conditions: Epiphora
• Interventions: Device: Sinopsys Lacrimal Stent

• Registration Number: NCT02240615
• Lead Sponsor: Sinopsys Surgical

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.

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Study Start: 2014-10
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinopsys Lacrimal Stent	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Stanford University; 🇺🇸 Stanford, California, United States

Center for Sight; 🇺🇸 Sarasota, Florida, United States

Eye Care Specialists; 🇺🇸 Kingston, Pennsylvania, United States

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States