Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE (OCCLUDE-I)

June 22, 2015 updated by: ArtVentive Medical Group, Inc.

PrOspective, MultiCenter Study for the Evaluation of PerformanCe of the ArtVentive Medical Group Peripheral EndoLuminal OcclUsion SystemTM in the Treatment of Varicocele or Pelvic Congestion SynDromE - OCCLUDE I

To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions:

  1. Cohort A: Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility
  2. Cohort B: Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • Poland
      • Lubin, Poland
        • University Hospital No4
  • Switzerland
      • Lugano, Switzerland
        • Ospedale Regionale di Lugano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects requiring permanent occlusion of the peripheral vessels for the following conditions:

  1. Cohort A: Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility.
  2. Cohort B: Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).

Description

Inclusion Criteria:

  1. Subjects aged ≥18 to ≤75 years.
  2. Subject with target vessels of 3.0 mm to 12.0 mm in diameter.
  3. Subject having indications to undergo embolotherapy consistent with clinical and pre-procedural angiographic assessment for spermatic vein origin varicocele (unilateral and/or bilateral) or pelvic congestion syndrome (pelvic venous incompetence).
  4. Subject is able and willing to comply with site standard medical follow-up, including one month follow-up visit.
  5. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form.

Exclusion Criteria:

  1. Subject has an active systemic infection.
  2. Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
  3. Subject has history of stroke within the prior 6 months.
  4. Subject has history of myocardial infarction with the prior 3 months.
  5. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
  6. Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or INR >1.5.
  7. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
  8. Subjects in whom venography or arteriography is contraindicated.
  9. Subjects with known hypersensitivity or contraindication to nickel or nitinol.
  10. Subject has a less than one year life expectancy.
  11. Subject is pregnant or breastfeeding.
  12. Subject with endometriosis or other ovarian / uterine pathology with adhesions that would interfere with the endpoints of this study.
  13. Subject with previous pelvic surgical intervention or embolotherapy for varicocele or ovarian varices that would interfere with the endpoints of this study, including but not limited to, recurrent varicocele or ovarian varices.
  14. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
  15. Subject has planned concomitant procedure at the time of the embolization (e.g., coil embolization, etc.).
  16. Subject is participating in another study of a device, medication, biologic, or other agent within 30 days or could, in the opinion of the investigator, impact the results of this study.
  17. Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre- and post-treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort A
Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility
Cohort B
Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Acute & 30 days
Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plaque distal to the device) at 30 days.
Acute & 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Acute & 30 days
Reduction of pain.
Acute & 30 days
Recurrent varices
Time Frame: 30 days
Recurrence of varices requiring repeat embolizations within 30 days.
30 days
Occlusion
Time Frame: 30 days
Sustained occlusion at 30 days follow-up.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ArtVentive Medical Group, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Geert Maleux, MD, UZ Leuven, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TD 0080/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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