Treatment for Venous Puncture

Phase-Based Estimates
1
Effectiveness
1
Safety
Delray Medical Center, Delray Beach, FL
Eligibility
18+
All Sexes
Eligible conditions
Venous Puncture

Study Summary

This study is evaluating whether a specialized closure device may help reduce bleeding following surgery.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes in patients with Venous Puncture. Measurement will happen over the course of Immediate.

1 month
Access Site Complication
Immediate
Hemostasis Time
Procedure Time

Trial Safety

Trial Design

2 Treatment Groups

Perclose Device

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Perclose Device
Other
Using the Perclose device when closing access for structural heart therapies.
Figure-of-eight
Other
Using the figure-of-eight closure technique when closing access for structural heart therapies.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 month for reporting.

Who is running the study

Principal Investigator
H. K.
Houman Khalili, MD
Delray Medical Center

Closest Location

Delray Medical Center - Delray Beach, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Venous Puncture by sharing your contact details with the study coordinator.