The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

NCT ID: NCT02240615

Last Updated: 2016-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epiphora

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sinopsys Lacrimal Stent

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.

Group Type EXPERIMENTAL

Sinopsys Lacrimal Stent

Intervention Type DEVICE

Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sinopsys Lacrimal Stent

Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sinopsys Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harry Ross, MD

Role: STUDY_DIRECTOR

Sinopsys Surgical Inc.

Teena Augostino

Role: STUDY_DIRECTOR

Sinopsys Surgical Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University

Stanford, California, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Center for Sight

Sarasota, Florida, United States

Site Status

Eye Care Specialists

Kingston, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SLS-US-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.