Trials / Withdrawn
WithdrawnNCT03140098
Evaluation of COVA™+ CARD in Adult Cardiac Surgery
Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Biom'Up France SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-02-01
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2017-05-04
- Last updated
- 2019-01-30
Source: ClinicalTrials.gov record NCT03140098. Inclusion in this directory is not an endorsement.