Hemostasis,SurgicalPhase 1/2NCT00507013
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose
A Phase 1/2 study testing QuickClose device in people with Hemostasis,Surgical, run by CardioDex at 1 site in Israel.
Trial summary
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure. Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis,Surgical
- What is being tested?
- QuickClose device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2007to Sep 2007
- Phase
- Phase 1/2
- 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
- The patient must be ≥ 18 years of age
- The patient or guardian must provide written informed consent
- The patient must be willing to comply with follow-up requirements
- The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days.
- Patient is eligible for same day discharge
- Procedural Inclusion:
- A intravascular procedure was preformed using 6 Fr introducer
- The introducer sheath is located in the common femoral artery
Who cannot join
- Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
- Any closure device has been used on the ipsilateral arterial site within the previous 180 days
- Any reentry of the ipsilateral site is planned within the next 6 weeks.
- History of surgical repair of blood vessels of the ipsilateral arterial site
- Significant bleeding diathesis or platelet dysfunction
- Thrombocytopenia (Plt count ≤ 100,000)
Show all 17Show fewer
- Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
- Has life expectancy of less than 1 year due to terminal illness
- Currently being treated for an infection
- Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days.
- INR results > 1.2 on day of procedure
- Experienced a Myocardial infarction (CK-MB ≥ 2x upper limits of normal) within the previous 72 hours
- Received thrombolytic within previous 72 hours
- Patient is currently enrolled in an investigational device or drug study which endpoints have not been met.
- Absent of pedal pulse
- Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease)
- Has Body Mass Index(BMI) <20, or BMI >40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.
Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete enrollment before enrollment into Group B begins. Patients will be monitored until 30 days after the procedure
Read the detailed description
The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success.
- Conditions
- Hemostasis,Surgical
- Being tested
- QuickClose device
- Keywords
- vascular closure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuickClose deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Not described Receives: Device: QuickClose device |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of complication
Measured: 30 days
Secondary outcomes (1)
time to hemostasis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostasis,SurgicalStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Investigators
- Amit Segev, MD, Principal investigator, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507013
- Sponsor's protocol ID
- RD 392-03
- Status last verified
- Apr 2008
- First submitted
- 23 Jul 2007
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT00507013
- Acronym / sponsor ID
- RD 392-03
- Conditions
- Hemostasis,Surgical
- Keywords
- vascular closure device
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CardioDexIndustry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- Jul 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Jul 2007 (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 QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.
Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete enrollment before enrollment into Group B begins. Patients will be monitored until 30 days after the procedure
Detailed description
The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Device: QuickClose device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must be ≥ 18 years of age
- The patient or guardian must provide written informed consent
- The patient must be willing to comply with follow-up requirements
- The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days.
- Patient is eligible for same day discharge
Key exclusion criteria (17 listed)
- Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
- Any closure device has been used on the ipsilateral arterial site within the previous 180 days
- Any reentry of the ipsilateral site is planned within the next 6 weeks.
- History of surgical repair of blood vessels of the ipsilateral arterial site
- Significant bleeding diathesis or platelet dysfunction
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 |
|---|---|---|
| QuickClose device | Device | 2 |
Primary outcome
rate of complication
Time frame: 30 days
1 secondary outcome
time to hemostasis
Time frame: 30 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 24 Apr 2008.
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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.
Amit Segev, MD principal investigator
The Chaim Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QuickClose device in people with Hemostasis,Surgical, run by CardioDex at 1 site in Israel.
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 8 inclusion and 17 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 24 Apr 2008. 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 Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
rate of complication (time frame: 30 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 24 Apr 2008.