Catheterization, Peripheral VenousViTAL-PIVCNCT07016607
Vital Peripheral Intravenous Catheter Feasibility
A study testing GPIV in people with Catheterization, Peripheral Venous, run by Embrace Medical Ltd. at 1 site in Dominican Republic.
Trial summary
The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral Venous
- What is being tested?
- GPIV
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDominican Republic
- Study dates
- 22 Nov 2021to 4 Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Male or female age ≥ 18.
- Requiring blood sample collection (roll-in subjects) or planned for PIVC (analyzable subjects)
- Signed informed consent.
Who cannot join
- Pregnancy or lactation.
- Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement).
- Previous venous grafts or surgery at the target vessel access site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study to Assess the Safety and Efficacy of the ViTal Peripheral Intravenous Catheter
The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is:
What is the first attempt success rate of the peripheral intravenous catheterization done using the study device?
Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.
- Conditions
- Catheterization, Peripheral Venous
- Being tested
- GPIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPIVDevice
Also called ViTal
The investigational device is a peripheral intravenous catheter with a passive fully automatic needlestick protection, with a glide-on-contact design of the plastic cannula tip featuring asymmetry, with the negative, convex slope in the plane perpendicular to the longitudinal axis of the tip resulting in bottom part of the cannula being shorter.
| Study group | Role | What they receive |
|---|---|---|
| GPIV | Experimental | If the eligibility criteria are fulfilled, up to 4 attempts will be made to achieve successful peripheral intravenous catheterization with the investigational device. All successive attempts will be made at a site different from the one(s) at which access has already failed. Receives: Device: GPIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
Proportion, in percent, of subjects with successful peripheral intravenous catheterization Successful PIVC is defined as withdrawal of non-pulsatile blood or infusion of saline without evidence of extravasation.
Failed PIVC is defined as extravasation with initial infusion, inability to draw blood, physician or nurse intervention for access or inability to obtain access.
Measured: Periprocedural
Secondary outcomes (1)
Device- and procedure-related adverse events
Incidence of the device- and procedure-related adverse events
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start22 Nov 2021
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, Peripheral VenousStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embrace Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016607
- Sponsor's protocol ID
- CLP-001
- Acronym
- ViTAL-PIVC
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 11 Jun 2025
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Safety and Efficacy of the ViTal Peripheral Intravenous Catheter
- ClinicalTrials.gov ID
- NCT07016607
- Acronym / sponsor ID
- ViTAL-PIVC / CLP-001
- Conditions
- Catheterization, Peripheral Venous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Embrace Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 11 Jun 2025 (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 goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is:
What is the first attempt success rate of the peripheral intravenous catheterization done using the study device?
Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPIV | Experimental | Device: GPIVIf the eligibility criteria are fulfilled, up to 4 attempts will be made to achieve successful peripheral intravenous catheterization with the investigational device. All successive attempts will be made at a site different from the one(s) at which access has already failed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female age ≥ 18.
- Requiring blood sample collection (roll-in subjects) or planned for PIVC (analyzable subjects)
- Signed informed consent.
Key exclusion criteria (3 listed)
- Pregnancy or lactation.
- Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement).
- Previous venous grafts or surgery at the target vessel access site.
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 |
|---|---|---|
| GPIVAlso: ViTalThe investigational device is a peripheral intravenous catheter with a passive fully automatic needlestick protection, with a glide-on-contact design of the plastic cannula tip featuring asymmetry, with the negative, convex slope in the plane perpendicular to the longitudinal axis of the tip resulting in bottom part of the cannula being shorter. | Device | GPIV |
Primary outcome
First attempt success rate
Time frame: Periprocedural
Proportion, in percent, of subjects with successful peripheral intravenous catheterization Successful PIVC is defined as withdrawal of non-pulsatile blood or infusion of saline without evidence of extravasation. Failed PIVC is defined as extravasation with initial infusion, inability to draw blood, physician or nurse intervention for access or inability to obtain access.
1 secondary outcome
Device- and procedure-related adverse events
Time frame: Periprocedural
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 11 Jun 2025.
- 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.
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?
A study testing GPIV in people with Catheterization, Peripheral Venous, run by Embrace Medical Ltd. at 1 site in Dominican Republic.
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 3 inclusion and 3 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 11 Jun 2025. 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 Dominican Republic. 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?
First attempt success rate (time frame: Periprocedural). 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 11 Jun 2025.