Midline CatheterNCT04911842
Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane
An observational study of Midline Catheter, run by Access Vascular Inc at 1 site in United States.
Trial summary
Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Midline Catheter
- What is being tested?
- HydroMID and TPU
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 18 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who needed a 4 Fr single lumen midline
Who may be able to join
- Subjects who have been inserted with the HydroMID by the vascular access group
- Subjects who have been inserted with a competitor 4 Fr single lumen by the vascular access team
Who cannot join
- Any off-label use (PICC lines cut to be midlines for any manufacturer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midline Failures: A Comparative, Retrospective Chart Review
Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials
- Conditions
- Midline Catheter
- Being tested
- HydroMID, TPU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroMIDDevice
Hydrophilic biomaterial
TPUDevice
Thermoplastic polyurethane
| Study group | Role | What they receive |
|---|---|---|
| TPU | Thermoplastic polyurethane Receives: Device: TPU | |
| HBM | Hydrophilic BioMaterial Receives: Device: HydroMID |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials.
Measured: retrospective review- March 2021 through May 2021
Secondary outcomes (1)
To compare the proportion of times the midline was used to successfully complete prescribed length.
Measured: retrospective review- March 2021 through May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start20 May 2021
- Primary completion2 Dec 2021
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midline CatheterStudies 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
- Retrospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Vascular Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911842
- Sponsor's protocol ID
- CLIN 21-001
- Status last verified
- Jan 2023
- First submitted
- 25 May 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Failures: A Comparative, Retrospective Chart Review
- ClinicalTrials.gov ID
- NCT04911842
- Acronym / sponsor ID
- CLIN 21-001
- Conditions
- Midline Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Access Vascular IncIndustry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 3 Jun 2021 (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.
Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPU | – | Device: TPUThermoplastic polyurethane |
| HBM | – | Device: HydroMIDHydrophilic BioMaterial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who needed a 4 Fr single lumen midline
Key inclusion criteria (2 listed)
- Subjects who have been inserted with the HydroMID by the vascular access group
- Subjects who have been inserted with a competitor 4 Fr single lumen by the vascular access team
Key exclusion criteria (1 listed)
- Any off-label use (PICC lines cut to be midlines for any manufacturer)
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 |
|---|---|---|
| HydroMIDHydrophilic biomaterial | Device | HBM |
| TPUThermoplastic polyurethane | Device | TPU |
Primary outcome
The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials.
Time frame: retrospective review- March 2021 through May 2021
1 secondary outcome
To compare the proportion of times the midline was used to successfully complete prescribed length.
Time frame: retrospective review- March 2021 through May 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Midline Catheter, run by Access Vascular Inc at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 2 Feb 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials. (time frame: retrospective review- March 2021 through May 2021). 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 2 Feb 2023.