EpiphoraEarly Phase 1NCT02240615
The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora
A Early Phase 1 study testing Sinopsys Lacrimal Stent in people with Epiphora, run by Sinopsys Surgical at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Epiphora
- What is being tested?
- Sinopsys Lacrimal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Feb 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically significant functional epiphora for at least three months
- Keros classification 1 or 2 skull base anatomy
Who cannot join
- Active infection
- Craniofacial deformity
- Severe inflammatory disease
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Eye Care Specialists
Kingston, Pennsylvania, 18704
Center for Sight
Sarasota, Florida, 34239
Stanford University
Stanford, California, 94305
About this study
Official title: The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With 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.
Read the detailed 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.
- Conditions
- Epiphora
- Being tested
- Sinopsys Lacrimal Stent
- Keywords
- Epiphora, Lacrimal Stent, Lacrimal System
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinopsys Lacrimal StentDevice
Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora
| Study group | Role | What they receive |
|---|---|---|
| Sinopsys Lacrimal Stent | Experimental | 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. Receives: Device: Sinopsys Lacrimal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six Months
Secondary outcomes (2)
Measurement of device insertion success
Measured: Procedural
Evaluation of all safety
Recording of all safety events that occur in the first six months of treatment
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpiphoraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinopsys Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Ross, MD, Study director, Sinopsys Surgical Inc.Teena Augostino, Study director, Sinopsys Surgical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240615
- Sponsor's protocol ID
- SLS-US-01
- Status last verified
- Feb 2016
- First submitted
- 11 Sep 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora
- ClinicalTrials.gov ID
- NCT02240615
- Acronym / sponsor ID
- SLS-US-01
- Conditions
- Epiphora
- Keywords
- Epiphora, Lacrimal Stent, Lacrimal System
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sinopsys SurgicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinopsys Lacrimal Stent | Experimental | Device: Sinopsys Lacrimal StentAll 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically significant functional epiphora for at least three months
- Keros classification 1 or 2 skull base anatomy
Key exclusion criteria (3 listed)
- Active infection
- Craniofacial deformity
- Severe inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinopsys Lacrimal StentProcedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora | Device | Sinopsys Lacrimal Stent |
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
PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline
2 secondary outcomes
Measurement of device insertion success
Time frame: Procedural
Evaluation of all safety
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Ross, MD study director
Sinopsys Surgical Inc.
Teena Augostino study director
Sinopsys Surgical Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sinopsys Lacrimal Stent in people with Epiphora, run by Sinopsys Surgical at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.