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
|Condition or disease|
|Varicocele Pelvic Congestion Syndrome|
Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions:
- 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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|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|
Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility
Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).
- 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.
- Pain [ Time Frame: Acute & 30 days ]Reduction of pain.
- Recurrent varices [ Time Frame: 30 days ]Recurrence of varices requiring repeat embolizations within 30 days.
- Occlusion [ Time Frame: 30 days ]Sustained occlusion at 30 days follow-up.
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
|University Hospital No4|
|Ospedale Regionale di Lugano|
|Principal Investigator:||Geert Maleux, MD||UZ Leuven, Belgium|