Suspended
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
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What is being tested
Expedial Vascular Access Graft
Device
Who is being recruted
End Stage Renal Disease
Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: March 2004
See protocol details
Summary
Principal SponsorLeMaitre Vascular
Last updated: July 8, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
Principal SponsorLeMaitre Vascular
Last updated: July 8, 2024
Sourced from a government-validated database.Claim as a partner
ProtocolThis section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
172 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
EligibilityResearchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
End Stage Renal Disease
Criteria
6 inclusion criteria required to participate
Patient has chronic renal failure and requires vascular access for hemodialysis
Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
Patient is male or female, 18 years of age or older
The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
Show More Criteria
10 exclusion criteria prevent from participating
Patient is unable to comply with the study follow-up
Patient has a known sensitivity to polyurethane or porcine heparin
Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
Patient has an immunodeficiency syndrome
Show More Criteria
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.
Study PlanFind out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study CentersThese are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 8 locations
Suspended
Suspended
Vascular Surgery AssociatesBaton Rouge, United States
Suspended
Montefiore Medical CenterBronx, United States
Suspended
Vascular SurgeryBronx, United States
Suspended8 Study Centers