Peripheral ICCNCT04920929
PICC Asymptomatic Thrombosis Study: A Pilot Study
A study testing Hydrophilic Biomaterial and Thermoplastic Polyurethane in people with Peripheral ICC, run by Access Vascular Inc at 1 site in United States.
Trial summary
The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral ICC
- What is being tested?
- Hydrophilic Biomaterial and Thermoplastic Polyurethane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 7 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient is indicated for a medically necessary PICC for therapeutic delivery medication
- Patient is eligible to receive a single lumen PICC
- Patient is an adult who is prescribed a PICC line
- Patient's expected duration of treatment requiring a PICC for a minimum of 16 days post device implantation
- Patient understands and is willing to comply with all study requirements and has voluntarily signed the Informed Consent Form (ICF).
Who cannot join
- Is pregnant, lactating, or is planning to become pregnant during the time of the study
- Has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
- Venous thrombosis in any portion of the vein to be catheterized
- Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
- Orthopedic or neurological conditions affecting the extremity
- Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start
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- Patients who are on anticoagulation therapy prior to the study (10-14 days). Note: (If patients are placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.)
- Patient has relinquished control of care to a guardian and/or facility
- Patient has any significant medical or physical condition that, in the opinion of the PI, would make the subject unsuitable for participation in the post market clinical evaluation
- Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.
Read the detailed description
This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.
- Conditions
- Peripheral ICC
- Being tested
- Hydrophilic Biomaterial, Thermoplastic Polyurethane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophilic BiomaterialDevice
Also called HydroPICC
PICC made out of a Hydrophilic Biomaterial
Thermoplastic PolyurethaneDevice
Also called PowerPICC
PICC made out of a thermoplastic polyurethane material
| Study group | Role | What they receive |
|---|---|---|
| Hydrophilic BioMaterial | Active comparator | Hydrophilic BioMaterial- HydroPICC Receives: Device: Hydrophilic Biomaterial |
| Thermoplastic Polyurethane | Active comparator | TPU- 4 French Single Lumen PowerPICC Receives: Device: Thermoplastic Polyurethane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic Thrombosis Rate
Rate of asymptomatic thrombosis measured using ultrasound technology for each group
Measured: 7 days post insertion
Secondary outcomes (2)
Symptomatic Thrombosis Rate
Rate of symptomatic thrombosis measured using ultrasound technology
Measured: 14 days post insertion
Symptomatic Thrombosis Rate
Rate of symptomatic thrombosis measured using ultrasound technology
Measured: 7 days post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start15 Jul 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: Enrollment too low, not meeting objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Vascular Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amit Bahl, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920929
- Sponsor's protocol ID
- CLIN 20-002
- Status last verified
- Nov 2022
- First submitted
- 4 Jun 2021
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
- ClinicalTrials.gov ID
- NCT04920929
- Acronym / sponsor ID
- CLIN 20-002
- Conditions
- Peripheral ICC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too low, not meeting objectives
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Access Vascular IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Posted 29 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.
Detailed description
This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control
| Arm | Type | Receives |
|---|---|---|
| Hydrophilic BioMaterial | Active comparator | Device: Hydrophilic BiomaterialHydrophilic BioMaterial- HydroPICC |
| Thermoplastic Polyurethane | Active comparator | Device: Thermoplastic PolyurethaneTPU- 4 French Single Lumen PowerPICC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is indicated for a medically necessary PICC for therapeutic delivery medication
- Patient is eligible to receive a single lumen PICC
- Patient is an adult who is prescribed a PICC line
- Patient's expected duration of treatment requiring a PICC for a minimum of 16 days post device implantation
- Patient understands and is willing to comply with all study requirements and has voluntarily signed the Informed Consent Form (ICF).
Key exclusion criteria (10 listed)
- Is pregnant, lactating, or is planning to become pregnant during the time of the study
- Has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
- Venous thrombosis in any portion of the vein to be catheterized
- Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
- Orthopedic or neurological conditions affecting the extremity
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 |
|---|---|---|
| Hydrophilic BiomaterialAlso: HydroPICCPICC made out of a Hydrophilic Biomaterial | Device | Hydrophilic BioMaterial |
| Thermoplastic PolyurethaneAlso: PowerPICCPICC made out of a thermoplastic polyurethane material | Device | Thermoplastic Polyurethane |
Primary outcome
Asymptomatic Thrombosis Rate
Time frame: 7 days post insertion
Rate of asymptomatic thrombosis measured using ultrasound technology for each group
2 secondary outcomes
Symptomatic Thrombosis Rate
Time frame: 14 days post insertion
Symptomatic Thrombosis Rate
Time frame: 7 days post insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Amit Bahl, MD principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrophilic Biomaterial and Thermoplastic Polyurethane in people with Peripheral ICC, 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 29 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Asymptomatic Thrombosis Rate (time frame: 7 days post insertion). 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 29 Nov 2022.