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

Varicocele Clinical Trial

— OCCLUDE-I  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02033863
• Other study ID #: TD 0080/07
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 8, 2014
• Last updated: June 22, 2015
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2015
• Source: ArtVentive Medical Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsPoland: Ethics CommitteeSwitzerland: Ethikkommission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Congestion Syndrome
• Syndrome
• Varicocele

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Poland	University Hospital No4	Lubin
Switzerland	Ospedale Regionale di Lugano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
ArtVentive Medical Group, Inc.

Countries where clinical trial is conducted

Belgium,  Poland,  Switzerland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pain	Reduction of pain.	Acute & 30 days	No
Secondary	Recurrent varices	Recurrence of varices requiring repeat embolizations within 30 days.	30 days	Yes
Secondary	Occlusion	Sustained occlusion at 30 days follow-up.	30 days	Yes