Evaluation of COVA™+ CARD in Adult Cardiac Surgery

January 28, 2019 updated by: Biom'Up France SAS

Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.

The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the collagen membrane according to the occurrence of peri and post-operative complications will be evaluated.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Assessment of the safety of COVA™+ CARD, collagen membrane to prevent adhesion appearance, in cardiac surgery in adult patients:

  • collection of post-operative complications, causality of the membrane
  • collection of complications in the 3-month period after the surgery, causality of the membrane
  • collection of peri-operative complications, causality of the membrane
  • collection of complications, 3 months after the surgery
  • assessment of the efficacy of COVA™+ CARD if re-operation
  • assessment of the surgeon's satisfaction

Study Type

Observational

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who will undergo a cardiac surgery.

Description

Inclusion Criteria:

  • 18 years of age or older
  • Cardiac surgery using COVA™+ CARD

Exclusion Criteria:

  • In accordance with the instruction for use (IFU) of the medical device.
  • Refusal of participation to the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
Time Frame: 3 months
Recording of complications reported in the 3-month postoperative period and determination of the causality of the collagen membrane.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
Time Frame: Hospitalization stay (up to 30 days)
Recording of the immediate postoperative complications and determination of the causality of the collagen membrane.
Hospitalization stay (up to 30 days)

Collaborators and Investigators

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

Sponsor

Biom'Up France SAS

Investigators

  • Principal Investigator: Francesco Madonna, CHU Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ANTICIPATED)

February 1, 2017

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

February 1, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ETC 2017-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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