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HemodialysisNCT00889564

HeRO Vascular Access Device Bacteremia Study

A study testing HeRO Vascular Access Device in people with Hemodialysis, run by Merit Medical Systems, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis
What is being tested?
HeRO Vascular Access Device
How many people
38 participants
Where
7 sitesUnited States
Study dates
Mar 2006to Mar 2007
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

  • 21 years of age or older.
  • Male or non-pregnant female.
  • Life expectancy less than 1 year.
  • ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
  • Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
  • Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
  • Ability to understand and provide written informed consent.
  • Willing and able to cooperate with follow-up examinations.

Who cannot join

  • Documented history of drug abuse within six months prior to enrollment.
  • "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
  • Currently being treated with another investigational device or drug.
  • Known bleeding diathesis or hypercoaguable state.
  • Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
  • Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants or low dose prednisone only (< 10 mg/day orally).
Show all 16Show fewer
  • Subjects with known or suspected concomitant active bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled. Subjects who are HIV + with CD4 count of < 200 are excluded. Subjects with bacteremia within the past six (6) weeks must have negative blood cultures one week after completing appropriate antibiotic therapy prior to enrollment.
  • Severe underlying co-morbidity or immediate life-threatening condition.
  • Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
  • Subjects with significant arterial occlusive disease which would preclude safe placement of an upper extremity hemodialysis access.
  • Subjects with history or findings on physical examination suggesting significant arterial insufficiency that could affect patient safety and/or device performance in the extremity planned for use with GVAS (i.e., steal syndrome, hand ischemia, peripheral arterial vascular disease, etc.).
  • Subjects with scheduled kidney transplant within the next 12 months.
  • Subjects with history of superior vena cava syndrome are excluded unless it was induced by previous access (these subjects can be enrolled).
  • Subjects with history of decreased cardiac output with ejection fraction < 20% and/or NYHA class III or IV. NYHA definitions: Class III - Subjects with marked limitation of activity; they are comfortable only at rest; Class IV - Subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
  • Subjects with history of uncorrected hypotension with systolic blood pressures routinely < 100 mg Hg.
  • Subjects who currently have a pacemaker or ICD in their central venous system on the same side where the GVAS device would be implanted.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • St. Joseph's Hospital

    Atlanta, Georgia, 30342

  • Bamberg County Hospital

    Bamberg, South Carolina, 29003

  • University of Miami / Cedars Medical Center

    Miami, Florida, 33125

  • Sentara Heart Hospital

    Norfolk, Virginia, 23507

  • North Memorial Medical Center

    Robbinsdale, Minnesota, 55422

  • Baptist Medical Center

    San Antonio, Texas, 78205

  • Southern Illinois University

    Springfield, Illinois, 62702

Other trials in United States

About this study

The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.

Conditions
Hemodialysis
Being tested
HeRO Vascular Access Device
Keywords
Vascular access for hemodialysis, Catheter dependent patients, Access challenged patients, Bacteremia, HeRO Vascular Access Device
Medical subject headings
Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeRO Vascular Access DeviceDevice

    Long-term subcutaneous vascular access device for hemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control

    Measured: 12 months

Secondary outcomes (1)

  1. Incidence of serious device or implant procedure-related serious adverse events and loss of secondary patency

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2009 (estimated)
  2. Study startMar 2006
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00889564
Sponsor's protocol ID
11-0050
Status last verified
Aug 2017
First submitted
27 Apr 2009
Last updated
8 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing HeRO Vascular Access Device in people with Hemodialysis, run by Merit Medical Systems, Inc. at 7 sites 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 8 inclusion and 16 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control (time frame: 12 months). 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 NCT00889564.

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 8 Aug 2017.

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