The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Epiphora Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240615
• Other study ID #: SLS-US-01
• Status: Completed
• Phase: Phase 0
• First received: September 11, 2014
• Last updated: February 11, 2016
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Sinopsys Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiphora

Intervention

Device:
• Sinopsys Lacrimal Stent
Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Center for Sight	Sarasota	Florida
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sinopsys Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measurement of device insertion success		Procedural	Yes
Secondary	Evaluation of all safety	Recording of all safety events that occur in the first six months of treatment	Six Months	Yes