Pilot Safety Study of Injectable SIS for Critical Limb Ischemia (CLIC)

December 19, 2017 updated by: Cook Group Incorporated

Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia

This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ostrava, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Injectable SIS
Device: Injectable SIS
Injectable SIS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Vaclav Prochazka, MD, University Hospital Ostrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 5, 2017

Study Completion (Actual)

November 6, 2017

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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