VaricoceleOCCLUDE-INCT02033863
Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE
An observational study of Varicocele and Pelvic Congestion Syndrome, run by ArtVentive Medical Group, Inc. at 3 sites in 3 countries.
Trial summary
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Varicocele, Pelvic Congestion Syndrome
- How many people
- 40 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2014to Jan 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
- 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.
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
Read the 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:
- 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).
- Conditions
- Varicocele, Pelvic Congestion Syndrome
- Keywords
- Varicocele, Pelvic Congestion Syndrome, Pelvic Venous Incompetence, Ovarian Varices
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Acute & 30 days
Secondary outcomes (3)
Pain
Reduction of pain.
Measured: Acute & 30 days
Recurrent varices
Recurrence of varices requiring repeat embolizations within 30 days.
Measured: 30 days
Occlusion
Sustained occlusion at 30 days follow-up.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- ArtVentive Medical Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert Maleux, MD, Principal investigator, UZ Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033863
- Sponsor's protocol ID
- TD 0080/07
- Acronym
- OCCLUDE-I
- Status last verified
- Jun 2015
- First submitted
- 8 Jan 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23703667
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02033863
- Acronym / sponsor ID
- OCCLUDE-I / TD 0080/07
- Conditions
- Varicocele, Pelvic Congestion Syndrome
- Keywords
- Varicocele, Pelvic Congestion Syndrome, Pelvic Venous Incompetence, Ovarian Varices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ArtVentive Medical Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Pain
Time frame: Acute & 30 days
Recurrent varices
Time frame: 30 days
Occlusion
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 23703667Venbrux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Maleux, MD principal investigator
UZ Leuven, Belgium
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele and Pelvic Congestion Syndrome, run by ArtVentive Medical Group, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Poland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Acute & 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.