InSeal Vascular Closure Device Clinical Study Protocol | NCT01896401

Studies
InSeal Vascular Closure Device Clinical Study Protocol

NCT01896401

Sponsor

InSeal Medical Ltd.

Status

Terminated

Last Update Posted

Feb 23, 2016Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Percutaneous Closure of Artery Access Sites

Interventions

InSeal's Vascular Closure Device

Countries

Germany

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 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Initiated a new study with improved device

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jul 6, 2013

First Submission Date that Met QC Criteria

Jul 6, 2013

First Posted Date

Jul 11, 2013Estimated

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 22, 2016

Last Update Posted Date

Feb 23, 2016Estimated

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 InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.

The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
InSeal's Vascular Closure Device	Experimental	Use of the experimental VCD to close the access site of the artery	Device: InSeal's Vascular Closure Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InSeal's Vascular Closure Device	Device		InSeal's Vascular Closure Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second		15 minutes

Secondary Outcomes

Measure	Description	Time Frame
2. Combined rate of closure-device related major adverse events in first month		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
Subject age is at least 18 years
Patient has signed most recent approved version of the Informed Consent
Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.

Exclusion Criteria:

Women Of Child Bearing Potential (WOCBP)
Legally non-competent patients
Patient participating in another clinical study at the time of the InSeal VCD study
Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
Prior vascular surgery or vascular graft in region of access site
Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided