Pilot Safety Study of Injectable SIS for Critical Limb Is... | NCT02145845

Studies
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

NCT02145845

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Dec 21, 2017Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Critical Limb Ischemia
Peripheral Arterial Disease
Peripheral Vascular Disease

Interventions

Injectable SIS

Countries

Czechia

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

Dec 2017

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

Apr 2014

Primary Completion Date

Jun 5, 2017Actual

Completion Date

Nov 6, 2017Actual

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

May 21, 2014

First Posted Date

May 23, 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

Dec 19, 2017

Last Update Posted Date

Dec 21, 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 intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

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

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Injectable SIS	Device: Injectable SIS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injectable SIS	Device	Injectable SIS	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and types of adverse events after treatment with the Cook Injectable SIS		180 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of critical limb ischemia
Rutherford 4-5 or Leriche-Fontaine IIIB
Patient unable to be treated by endovascular or surgical means

Exclusion Criteria:

Patient's age is <21
Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
Patient has had a previous surgery, within 30 days of the study procedure
Patient has any planned surgical or interventional procedure within 30 days after the study procedure
Patient has a life expectancy less than 1 year
Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue
Additional restrictions as specified in the Clinical Investigation Plan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vaclav Prochazka, MD	University Hospital Ostrava	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ostrava		Ostrava		708 52	Czechia

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided