Trauma InjuryNCT04218292
Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan
An observational study of Trauma Injury and Bleeding, run by KA Medical, LLC at 1 site in Germany.
Trial summary
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Bleeding
- What is being tested?
- Micro Plug Set
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2020to 28 Feb 2022
- 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 requiring routine standard of care for peripheral embolization. Some of the patients will be liver cancer patients undergoing palliative treatment with SIRT who have a life expectancy that may be less than 12 months. Other patients may be treated for trauma or bleeding.
Who may be able to join
- Subject is scheduled for arterial embolization in the peripheral vasculature.
- Subject is greater than 18 years of age
Who cannot join
- Subject is unable to give informed consent
- Subject is pregnant or breastfeeding
- Subject has allergy to nickel
- Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.
- Conditions
- Trauma Injury, Bleeding
- Being tested
- Micro Plug Set
- Medical subject headings
- Accidental Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro Plug SetDevice
The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of serious device-related and procedure-related adverse events
Rate of serious device-related and procedure-related adverse events
Measured: 12 months
Secondary outcomes (1)
Rate of successful delivery of the device
Rate of successful delivery of the Micro Plug device to the intended position.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start31 Mar 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KA Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merit Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Maciej Pech, MD, Principal investigator, University Hospital Magdeburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218292
- Sponsor's protocol ID
- PMCF 24October2019
- Other IDs
- KAM-P4-21-01
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan
- ClinicalTrials.gov ID
- NCT04218292
- Acronym / sponsor ID
- PMCF 24October2019
- Conditions
- Trauma Injury, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KA Medical, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Merit Medical Systems, Inc.
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 6 Jan 2020 (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.
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.
Study design
- Observational model
- Cohort
- 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 requiring routine standard of care for peripheral embolization. Some of the patients will be liver cancer patients undergoing palliative treatment with SIRT who have a life expectancy that may be less than 12 months. Other patients may be treated for trauma or bleeding.
Key inclusion criteria (2 listed)
- Subject is scheduled for arterial embolization in the peripheral vasculature.
- Subject is greater than 18 years of age
Key exclusion criteria (4 listed)
- Subject is unable to give informed consent
- Subject is pregnant or breastfeeding
- Subject has allergy to nickel
- Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.
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 |
|---|---|---|
| Micro Plug SetThe Micro Plug Set is indicated for arterial embolization in the peripheral vasculature. | Device | – |
Primary outcome
Rate of serious device-related and procedure-related adverse events
Time frame: 12 months
Rate of serious device-related and procedure-related adverse events
1 secondary outcome
Rate of successful delivery of the device
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- 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.
Maciej Pech, MD principal investigator
University Hospital Magdeburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and Bleeding, run by KA Medical, LLC at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Rate of serious device-related and procedure-related adverse events (time frame: 12 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 23 Apr 2021.