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NCT03140098 Clinical Trial

Evaluation of COVA™+ CARD in Adult Cardiac Surgery

Safety Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03140098
Other study ID # ETC 2017-002
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 2017
Est. completion date February 2018

Study information
Verified date January 2019
Source Biom'Up SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• cardiac surgery requiring a collagen membrane COVA™+
At the end of the cardiac surgery, the collagen membrane is implanted on the dissection area in order to prevent the formation of postoperative adhesions.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Biom'Up SA

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the tolerance of COVA™+ CARD in cardiac surgery Recording of complications reported in the 3-month postoperative period and determination of the causality of the collagen membrane. 3 months
Secondary Evaluation of the tolerance of COVA™+ CARD in cardiac surgery Recording of the immediate postoperative complications and determination of the causality of the collagen membrane. Hospitalization stay (up to 30 days)
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