VenipuncturePhase 3VeinGERNCT03139045
Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics
A Phase 3 study testing Venous puncture in elderly patients in people with Venipuncture and Geriatric, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Venipuncture, Geriatric
- What is being tested?
- Venous puncture in elderly patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Dec 2021
- Phase
- Phase 3
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged 75 years and over
- Patient hospitalized in a department of acute geriatrics, whose venipuncture was prescribed
Who cannot join
- Patient not affiliated to a social security scheme
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.
- Conditions
- Venipuncture, Geriatric
- Being tested
- Venous puncture in elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous puncture in elderly patientsBiological
Venous puncture in elderly patients
| Study group | Role | What they receive |
|---|---|---|
| Venous puncture using VVV at the beginning of the procedure | Active comparator | Not described Receives: Biological: Venous puncture in elderly patients |
| Venous puncture without VVV | Active comparator | Not described Receives: Biological: Venous puncture in elderly patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the number of attempts to place the venous catheter for venipuncture
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139045
- Sponsor's protocol ID
- PI2016_843_0030
- Acronym
- VeinGER
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2017
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics
- ClinicalTrials.gov ID
- NCT03139045
- Acronym / sponsor ID
- VeinGER / PI2016_843_0030
- Conditions
- Venipuncture, Geriatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 May 2017 (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.
Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous puncture using VVV at the beginning of the procedure | Active comparator | Biological: Venous puncture in elderly patients |
| Venous puncture without VVV | Active comparator | Biological: Venous puncture in elderly patients |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient aged 75 years and over
- Patient hospitalized in a department of acute geriatrics, whose venipuncture was prescribed
Key exclusion criteria (2 listed)
- Patient not affiliated to a social security scheme
- Patient under legal protection
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 |
|---|---|---|
| Venous puncture in elderly patientsVenous puncture in elderly patients | Biological | Venous puncture using VVV at the beginning of the procedure, Venous puncture without VVV |
Primary outcome
Quantification of the number of attempts to place the venous catheter for venipuncture
Time frame: 3 days
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 18 Jan 2023.
- 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 Phase 3 study testing Venous puncture in elderly patients in people with Venipuncture and Geriatric, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 2 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 18 Jan 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantification of the number of attempts to place the venous catheter for venipuncture (time frame: 3 days). 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 18 Jan 2023.