UnknownNot Applicable

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

Belgium, Poland, Switzerland40 participantsStarted 2014-07

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Safety

Timeframe: Acute & 30 days

NCT IDNCT02033863

SponsorArtVentive Medical Group, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.