OTX-14-002: Device Exposure Registry | NCT02309736

Studies
OTX-14-002: Device Exposure Registry

NCT02309736

Sponsor

Ocular Therapeutix, Inc.

Status

Withdrawn

Last Update Posted

Feb 5, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Endophthalmitis

Interventions

ReSure Sealant

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

On going discussions with FDA

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Apr 2020Estimated

Completion Date

Not provided

First Submitted Date

Dec 3, 2014

First Submission Date that Met QC Criteria

Dec 3, 2014

First Posted Date

Dec 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
ReSure Sealant	Device

Measure	Description	Time Frame
Occurrence of endophthalmitis		Day 30

Eligibility Module

Eligibility Criteria

All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009877	Endophthalmitis

Ancestor Terms

ID	Term
D015817	Eye Infections
D007239	Infections
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided