Venous PunctureNCT04831008
Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure
A study testing Figure-of-eight suture and Perclose Device in people with Venous Puncture, run by Delray Medical Center at 1 site in United States.
Trial summary
The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Puncture
- What is being tested?
- Figure-of-eight suture and Perclose Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 13 Dec 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.
Who cannot join
- Patients who do not consent
- Minors or those unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.
The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.
Read the detailed description
Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.
- Conditions
- Venous Puncture
- Being tested
- Figure-of-eight suture, Perclose Device
- Keywords
- Perclose Device, Figure-of-eight suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Figure-of-eight sutureOther
Using the figure-of-eight closure technique when closing access for structural heart therapies.
Perclose DeviceOther
Using the Perclose device when closing access for structural heart therapies.
| Study group | Role | What they receive |
|---|---|---|
| Figure-of-eight | Active comparator | Using the figure-of-eight closure technique when closing access for structural heart therapies. Receives: Other: Figure-of-eight suture |
| Perclose Device | Active comparator | Using the Perclose device when closing access for structural heart therapies. Receives: Other: Perclose Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis Time
To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
Measured: Immediate
Procedure Time
Measured: Immediate
Access Site Complication
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start6 Aug 2020
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delray Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Atlantic University
- Responsible party
- Principal investigator, Houman Khalili MD, Delray Medical Center
- Investigators
- Houman Khalili, MD, Principal investigator, Delray Medical CenterBrijeshwar Maini, Principal investigator, Delray Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831008
- Sponsor's protocol ID
- 2020-149
- Status last verified
- Jan 2023
- First submitted
- 31 Mar 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.
- ClinicalTrials.gov ID
- NCT04831008
- Acronym / sponsor ID
- 2020-149
- Conditions
- Venous Puncture
- Keywords
- Perclose Device, Figure-of-eight suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Delray Medical CenterUniversity, hospital or other
- Collaborators
- Florida Atlantic University
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 5 Apr 2021 (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 study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.
Detailed description
Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Figure-of-eight | Active comparator | Other: Figure-of-eight sutureUsing the figure-of-eight closure technique when closing access for structural heart therapies. |
| Perclose Device | Active comparator | Other: Perclose DeviceUsing the Perclose device when closing access for structural heart therapies. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.
Key exclusion criteria (2 listed)
- Patients who do not consent
- Minors or those unable to consent
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 |
|---|---|---|
| Figure-of-eight sutureUsing the figure-of-eight closure technique when closing access for structural heart therapies. | Other | Figure-of-eight |
| Perclose DeviceUsing the Perclose device when closing access for structural heart therapies. | Other | Perclose Device |
Primary outcome
Hemostasis Time
Time frame: Immediate
To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
Procedure Time
Time frame: Immediate
Access Site Complication
Time frame: 1 month
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 Jan 2023.
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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.
Houman Khalili, MD principal investigator
Delray Medical Center
Brijeshwar Maini principal investigator
Delray Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Figure-of-eight suture and Perclose Device in people with Venous Puncture, run by Delray Medical Center at 1 site in United States.
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 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 11 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 United States. 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?
Hemostasis Time (time frame: Immediate). The study lists 3 primary outcomes in all. 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 Jan 2023.