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

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ClinicalTrials.gov Identifier: NCT02033863
Recruitment Status : Unknown
Verified June 2015 by ArtVentive Medical Group, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : January 13, 2014
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
ArtVentive Medical Group, Inc.

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

Condition or disease
Varicocele Pelvic Congestion Syndrome

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: 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
Study Start Date : July 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Group/Cohort
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain [ Time Frame: Acute & 30 days ]
    Reduction of pain.

  2. Recurrent varices [ Time Frame: 30 days ]
    Recurrence of varices requiring repeat embolizations within 30 days.

  3. Occlusion [ Time Frame: 30 days ]
    Sustained occlusion at 30 days follow-up.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033863


Locations
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Belgium
UZ Leuven
Leuven, Belgium
Poland
University Hospital No4
Lubin, Poland
Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
Sponsors and Collaborators
ArtVentive Medical Group, Inc.
Investigators
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Principal Investigator: Geert Maleux, MD UZ Leuven, Belgium

Additional Information:

Publications:
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Responsible Party: ArtVentive Medical Group, Inc.
ClinicalTrials.gov Identifier: NCT02033863     History of Changes
Other Study ID Numbers: TD 0080/07
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by ArtVentive Medical Group, Inc.:
Varicocele
Pelvic Congestion Syndrome
Pelvic Venous Incompetence
Ovarian Varices

Additional relevant MeSH terms:
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Syndrome
Varicocele
Disease
Pathologic Processes
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases