Venous PunctureECLIPSENCT01602133
Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter
A study testing peripheral venous puncture in people with Venous Puncture, run by Prodimed SAS at 1 site in France.
Trial summary
Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Puncture
- What is being tested?
- peripheral venous puncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Jun 2014
- 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
- Hospitalized patients with need of an intravenous therapy on peripheral line
- Unsuccessful attempts at establishing a peripheral intravenous line by nurse
- Age over 18 YO
- Written informed consent obtained
Who cannot join
- pregnant woman
- local contra-indication for venous puncture
- unconscious patient
- need of intravenous therapy requiring central line
Trial locations and contacts
1 site in 1 country.
pascal meyer, MD contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91 100
About this study
Official title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter
Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.
- Conditions
- Venous Puncture
- Being tested
- peripheral venous puncture
- Keywords
- venous puncture, seldinger technique, ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral venous punctureProcedure or surgery
Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.
| Study group | Role | What they receive |
|---|---|---|
| one intervention arm | Experimental | Not described Receives: Procedure: peripheral venous puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of use of the catheter measured in number of days
Measured: seven days
Secondary outcomes (1)
adverse event during the period of use of the catheter
extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous PunctureStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prodimed SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Meyer, MD, Principal investigator, Centre Hospitalier Sud Francilien- Corbeil- France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602133
- Sponsor's protocol ID
- 2011-A01570-41
- Acronym
- ECLIPSE
- Status last verified
- Oct 2012
- First submitted
- 17 May 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
PubMed 36507736
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter
- ClinicalTrials.gov ID
- NCT01602133
- Acronym / sponsor ID
- ECLIPSE / 2011-A01570-41
- Conditions
- Venous Puncture
- Keywords
- venous puncture, seldinger technique, ultrasound guidance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Prodimed SASIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 May 2012 (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.
Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one intervention arm | Experimental | Procedure: peripheral venous puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients with need of an intravenous therapy on peripheral line
- Unsuccessful attempts at establishing a peripheral intravenous line by nurse
- Age over 18 YO
- Written informed consent obtained
Key exclusion criteria (4 listed)
- pregnant woman
- local contra-indication for venous puncture
- unconscious patient
- need of intravenous therapy requiring central line
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 |
|---|---|---|
| peripheral venous punctureUltrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method. | Procedure or surgery | one intervention arm |
Primary outcome
length of use of the catheter measured in number of days
Time frame: seven days
1 secondary outcome
adverse event during the period of use of the catheter
Time frame: seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Derived from this study: PubMed 36507736Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
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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.
pascal meyer, MD contact
Pascal Meyer, MD principal investigator
Centre Hospitalier Sud Francilien- Corbeil- France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral venous puncture in people with Venous Puncture, run by Prodimed SAS 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pascal meyer, MD (pas.meyer@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of use of the catheter measured in number of days (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602133, which also lists 1 linked publication.
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 25 Oct 2012.