SafetyNCT03140098
Evaluation of COVA™+ CARD in Adult Cardiac Surgery
An observational study of Safety and Tolerance, run by Biom'Up France SAS.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- cardiac surgery requiring a collagen membrane COVA™+
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo a cardiac surgery.
Who may be able to join
- 18 years of age or older
- Cardiac surgery using COVA™+ CARD
Who cannot join
- In accordance with the instruction for use (IFU) of the medical device.
- Refusal of participation to the study
About this study
Official title: 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.
Read the 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
- Being tested
- cardiac surgery requiring a collagen membrane COVA™+
- Keywords
- Collagen membrane, Cardiac surgery, Postoperative complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgery requiring a collagen membrane COVA™+Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: Hospitalization stay (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startFeb 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: Decision not to pursue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biom'Up France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Madonna, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140098
- Sponsor's protocol ID
- ETC 2017-002
- Status last verified
- Jan 2019
- First submitted
- 26 Apr 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.
- ClinicalTrials.gov ID
- NCT03140098
- Acronym / sponsor ID
- ETC 2017-002
- Keywords
- Collagen membrane, Cardiac surgery, Postoperative complication
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Decision not to pursue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biom'Up France SASIndustry (pharma, biotech, devices)
- Study start
- Feb 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo a cardiac surgery.
Key inclusion criteria (2 listed)
- 18 years of age or older
- Cardiac surgery using COVA™+ CARD
Key exclusion criteria (2 listed)
- In accordance with the instruction for use (IFU) of the medical device.
- Refusal of participation to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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.
1 secondary outcome
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
Time frame: Hospitalization stay (up to 30 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Potential interest of a new absorbable collagen membrane in the prevention of adhesions in paediatric cardiac surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Madonna principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Tolerance, run by Biom'Up France SAS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.