CyPass Clinical Experience Study | NCT01097174

Studies
CyPass Clinical Experience Study

NCT01097174

Sponsor

Transcend Medical, Inc.

Status

Completed

Last Update Posted

May 15, 2017Actual

Enrollment

555Actual

Phase

Not provided

Conditions

Open Angle Glaucoma (OAG)

Interventions

CyPass Micro-Stent

Countries

Austria
Bulgaria
Germany
Italy
Poland
Spain

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Mar 30, 2010

First Submission Date that Met QC Criteria

Mar 30, 2010

First Posted Date

Apr 1, 2010Estimated

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

May 12, 2017

Last Update Posted Date

May 15, 2017Actual

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

This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.

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

555Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CyPass Micro-stent		Patients in whom CyPass Micro-stent implantation was attempted.	Device: CyPass Micro-Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CyPass Micro-Stent	Device	The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye.	CyPass Micro-stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of intraoperative and postoperative adverse events		Day 0 - Year 3

Secondary Outcomes

Measure	Description	Time Frame
Intraocular pressure (IOP) reduction		1 - 36 months postoperatively
Ocular hypotensive medication use		1 - 36 months postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of OAG
IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)

Exclusion Criteria:

Acute angle closure, narrow angle, uveitic or neovascular glaucoma
Normal tension glaucoma

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

Glaucoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tsontcho (Sean) Ianchulev, MD, MPH	Transcend Medical, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic		Salzburg			Austria
Specialized Hospital for Active Treatment of Ophthalmologic Diseases

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided