The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Sinopsys Surgical

Status and phase: Completed; Early Phase 1

Conditions: Epiphora

Treatments: Device: Sinopsys Lacrimal Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02240615

SLS-US-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 22+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Sinopsys Lacrimal Stent

Experimental group

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.

Treatment:

Device: Sinopsys Lacrimal Stent