Primary CareAVONCT02015845
Evaluation of Accuvein in Obese Patients
A study testing Accuvein and Routine technique in people with Primary Care, run by Hopital Foch at 1 site in France.
Trial summary
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Care
- What is being tested?
- Accuvein and Routine technique
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to May 2017
- 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
- obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter
Who cannot join
- pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Hospitalier Franco-Britannique
Levallois-Perret, Hauts de Seine, 92300
About this study
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.
- Conditions
- Primary Care
- Being tested
- Accuvein, Routine technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuveinDevice
Routine techniqueDevice
Placement of peripheral intravenous catheters using the routine technique
| Study group | Role | What they receive |
|---|---|---|
| Accuvein | Experimental | Use of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients Receives: Device: Accuvein |
| Routine technique | Active comparator | Routine technique used to insert a peripheral intravenous catheters in obese patients. Receives: Device: Routine technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of success of the first vein puncture
Successful successful placement of IV catheter
Measured: one hour
Secondary outcomes (1)
Score of evaluation of the device
Evaluation of the device by the operator and the patient
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: recrutment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015845
- Sponsor's protocol ID
- 2013/19
- Other IDs
- 2013-A00777-38
- Acronym
- AVO
- Status last verified
- May 2017
- First submitted
- 5 Dec 2013
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuvein in Obese Patients
- ClinicalTrials.gov ID
- NCT02015845
- Acronym / sponsor ID
- AVO / 2013/19
- Conditions
- Primary Care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recrutment difficulties
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Dec 2013 (estimated)
- 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 objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accuvein | Experimental | Device: AccuveinUse of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients |
| Routine technique | Active comparator | Device: Routine techniqueRoutine technique used to insert a peripheral intravenous catheters in obese patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter
Key exclusion criteria (1 listed)
- pregnant woman
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 |
|---|---|---|
| Accuvein | Device | Accuvein |
| Routine techniquePlacement of peripheral intravenous catheters using the routine technique | Device | Routine technique |
Primary outcome
Percentage of success of the first vein puncture
Time frame: one hour
Successful successful placement of IV catheter
1 secondary outcome
Score of evaluation of the device
Time frame: one hour
Results and safety
The study was stopped early (reason given: recrutment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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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 Accuvein and Routine technique in people with Primary Care, run by Hopital Foch 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 1 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: stopped early, as of the sponsor's last update on 19 May 2017. 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.
Are results available for this study?
The study was stopped early (reason given: recrutment difficulties). Results are not available in the source record.
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?
Percentage of success of the first vein puncture (time frame: one hour). 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 19 May 2017.