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NCT Number: NCT02240615

The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

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.

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Key information

Conditions

Epiphora Eye Diseases Lacrimal Apparatus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinopsys Lacrimal Stent

Device

Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

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.

    Time frame: Six Months

    PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline

Secondary outcomes

  1. Measurement of device insertion success

    Time frame: Procedural

  2. Evaluation of all safety

    Time frame: Six Months

    Recording of all safety events that occur in the first six months of treatment

Sponsors and collaborators

Lead sponsor

Sinopsys Surgical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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