Peripheral ICCNCT04656548
A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line
An observational study of Peripheral ICC and PICC, run by Access Vascular Inc at 1 site in United States.
Trial summary
This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral ICC, PICC
- What is being tested?
- HydroPICC
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 23 Apr 2021
- 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: Any patients at the study site that received a 4 Fr single lumen PICC line from Aug 2020 through Oct 2020.
Who may be able to join
- Subjects who have been inserted with the HydroPICC during a specific time range.
- During the same time period, any competitor 4 Fr single lumen placed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.
Read the detailed description
Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020.
The two groups will be HydroPICCs and the standard of care for the facility.
A comparison of multiple endpoints will be evaluated between the two groups.
- Conditions
- Peripheral ICC, PICC
- Being tested
- HydroPICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroPICCDevice
Also called Standard of Care
PICC lines
| Study group | Role | What they receive |
|---|---|---|
| HydroPICC | Cohort who received the HydroPICC Receives: Device: HydroPICC | |
| Standard of Care | Cohort who received something different than HydroPICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intended dwell time based on a comparison of the actual dwell time to the intended time
Comparison of actual vs intended dwell times of each arm
Measured: August 2020 through October 2020
Secondary outcomes (1)
Comparison of failure rates
Compare the failure rates between the two arms
Measured: August 2020 through October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start13 Nov 2020
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral ICCStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Vascular Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Bunch, Principal investigator, ProVasc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656548
- Sponsor's protocol ID
- CLIN 20-001
- Status last verified
- May 2021
- First submitted
- 1 Dec 2020
- Last updated
- 26 May 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 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line
- ClinicalTrials.gov ID
- NCT04656548
- Acronym / sponsor ID
- CLIN 20-001
- Conditions
- Peripheral ICC, PICC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Access Vascular IncIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 7 Dec 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 a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.
Detailed description
Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020.
The two groups will be HydroPICCs and the standard of care for the facility.
A comparison of multiple endpoints will be evaluated between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HydroPICC | – | Device: HydroPICCCohort who received the HydroPICC |
| Standard of Care | – | –Cohort who received something different than HydroPICC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients at the study site that received a 4 Fr single lumen PICC line from Aug 2020 through Oct 2020.
Key inclusion criteria (2 listed)
- Subjects who have been inserted with the HydroPICC during a specific time range.
- During the same time period, any competitor 4 Fr single lumen placed.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| HydroPICCAlso: Standard of CarePICC lines | Device | HydroPICC |
Primary outcome
Intended dwell time based on a comparison of the actual dwell time to the intended time
Time frame: August 2020 through October 2020
Comparison of actual vs intended dwell times of each arm
1 secondary outcome
Comparison of failure rates
Time frame: August 2020 through October 2020
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 26 May 2021.
- Individual participant dataSharing planned: No
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.
Joseph Bunch principal investigator
ProVasc
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 Peripheral ICC and PICC, 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 26 May 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 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?
Intended dwell time based on a comparison of the actual dwell time to the intended time (time frame: August 2020 through October 2020). 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 26 May 2021.