An Early Phase 1 interventional study of Sinopsys Lacrimal Stent in Epiphora, sponsored by Sinopsys Surgical. Completed at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2016-02-12.
Sponsored by Sinopsys Surgical · Early Phase 1, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Lacrimal Apparatus Diseases; 2 are open to participants now.
This study's enrollment of 10 is below the median of 28 across 27 interventional studies indexed under Lacrimal Apparatus Diseases.
Browse Lacrimal Apparatus Diseases studies →Sinopsys Surgical is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Device: Sinopsys Lacrimal Stent
Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora
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
Time frame: Six Months
Measurement of device insertion success
Time frame: Procedural
Evaluation of all safety
Recording of all safety events that occur in the first six months of treatment
Time frame: Six Months
The record gives a start of Oct 2014, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Sinopsys Surgical