Clinical Trial: The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora
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 Summary: 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.
Sponsor: Sinopsys Surgical
Current Primary Outcome: 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 ]
Original Primary Outcome:
- 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 ]
- Assessment of treatment emergent adverse events [ Time Frame: Six Months ]
Current Secondary Outcome:
- Measurement of device insertion success [ Time Frame: Procedural ]
- Evaluation of all safety [ Time Frame: Six Months ]Recording of all safety events that occur in the first six months of treatment
Original Secondary Outcome: Measurement of device insertion success [ Time Frame: Procedural ]
Information By: Sinopsys Surgical
Dates:
Date Received: September 11, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016