Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE

NCT02033863 | Unknown DMC

• 1 other identifier: TD 0080/07
• Study Type: observational
• Target: 40
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Varicocele; Pelvic Congestion Syndrome

Keywords

Varicocele; Pelvic Congestion Syndrome; Pelvic Venous Incompetence; Ovarian Varices

Outcome Measures

Primary Outcomes (1)

• Safety

  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 Outcomes (3)

• Pain

  Acute & 30 days

• Recurrent varices

  30 days

• Occlusion

  30 days

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Subjects aged ≥18 to ≤75 years.
• Subject with target vessels of 3.0 mm to 12.0 mm in diameter.
• 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).
• Subject is able and willing to comply with site standard medical follow-up, including one month follow-up visit.
• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form.

You may not qualify if:

• Subject has an active systemic infection.
• Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
• Subject has history of stroke within the prior 6 months.
• Subject has history of myocardial infarction with the prior 3 months.
• 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.
• Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or INR \>1.5.
• 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).
• Subjects in whom venography or arteriography is contraindicated.
• Subjects with known hypersensitivity or contraindication to nickel or nitinol.
• Subject has a less than one year life expectancy.
• Subject is pregnant or breastfeeding.
• Subject with endometriosis or other ovarian / uterine pathology with adhesions that would interfere with the endpoints of this study.
• 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.
• Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
• Subject has planned concomitant procedure at the time of the embolization (e.g., coil embolization, etc.).

Sponsors & Collaborators

• ArtVentive Medical Group, Inc.: lead

Study Sites (3)

UZ Leuven

Leuven, Belgium

Location

University Hospital No4

Lubin, Poland

Location

Ospedale Regionale di Lugano

Lugano, Switzerland

Location

Related Publications (1)

• Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24.

  PMID: 23703667 BACKGROUND

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Geert Maleux, MD

  UZ Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 13, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

CH (1); BE (1); PL (1)