Pelvic Congestion SyndromeREPiVACNCT04115137
Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC
An observational study of Pelvic Congestion Syndrome and Pelvic Varicose Veins, run by Group of Research in Minimally Invasive Techniques at 2 sites in Spain.
Trial summary
Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Congestion Syndrome, Pelvic Varicose Veins, Follow-up Study
- What is being tested?
- pelvic varicose veins plug embolization
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2019to 1 Jan 2021
- How long will I take part?
- 2 Years
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome
Who may be able to join
- Female < 18 years
- Present symptomatology
- At least one image diagnosis
Who cannot join
- Female > 18
- Non present symptomatology
- Non diagnosis
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Vithas Nisa Pardo de Aravaca
Madrid, 28023
Jose Urbano, M.D, 34 915 12 90 00, jurbano34@gmail.com
- Recruiting
Lozano Blesa Universitary Hospital
Zaragoza, Aragon, 50009
Miguel Angel De Gregorio, Phd, 34976765768, mgregori@unizar.es
About this study
Official title: Multicentric Spanish Record of Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer - Pelvic Congestion Syndrome: Study of Efficacy and Safety
Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.
Read the detailed description
This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins.
Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months
- Conditions
- Pelvic Congestion Syndrome, Pelvic Varicose Veins, Follow-up Study, Embolization, Therapeutic, Observational Study
- Being tested
- pelvic varicose veins plug embolization
- Keywords
- Pelvic Congestion Syndrome, amplatzer vascular plug, Vascular plug, metallic embolization device, Chronic pelvic pain, embolization procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic varicose veins plug embolizationDevice
pelvic varicose veins plug embolization
| Study group | Role | What they receive |
|---|---|---|
| Women with pelvic congestion syndrome | Women older than 18 years At least 1 birth Present symptoms Receives: Device: pelvic varicose veins plug embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embolization of pelvic varicose veins using AVP
39/5000 absence of symptoms and vaginal ultrasound
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Mar 2019
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jan 2021 (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 Pelvic Congestion SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Group of Research in Minimally Invasive Techniques
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel A De Gregorio, Ph.D., Principal investigator, Minimal Invasive Techniques Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115137
- Sponsor's protocol ID
- GITMI-05
- Acronym
- REPiVAC
- Status last verified
- Oct 2019
- First submitted
- 11 Jul 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamamoto-Ramos M, De Gregorio MA, de Blas I, Sierre S, Urbano J, Mendez S, Abadal JM, Perez-Lafuente M, Aguirre N, Guirola JA. Understanding Recurrence in Pelvic Venous Disorders through the Symptoms-Varices-Pathophysiology Classification: A Multicenter Prospective Cohort Study. J Vasc Interv Radiol. 2026 Jul;37(7):108758. doi: 10.1016/j.jvir.2026.108758. Epub 2026 Mar 25.
PubMed 41895652
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Spanish Record of Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer - Pelvic Congestion Syndrome: Study of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT04115137
- Acronym / sponsor ID
- REPiVAC / GITMI-05
- Conditions
- Pelvic Congestion Syndrome, Pelvic Varicose Veins, Follow-up Study, Embolization, Therapeutic, Observational Study
- Keywords
- Pelvic Congestion Syndrome, amplatzer vascular plug, Vascular plug, metallic embolization device, Chronic pelvic pain, embolization procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Group of Research in Minimally Invasive TechniquesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 3 Oct 2019 (actual)
- 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.
Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.
Detailed description
This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins.
Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pelvic congestion syndrome | – | Device: pelvic varicose veins plug embolizationWomen older than 18 years At least 1 birth Present symptoms |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome
Key inclusion criteria (3 listed)
- Female < 18 years
- Present symptomatology
- At least one image diagnosis
Key exclusion criteria (3 listed)
- Female > 18
- Non present symptomatology
- Non diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic varicose veins plug embolizationpelvic varicose veins plug embolization | Device | Women with pelvic congestion syndrome |
Primary outcome
Embolization of pelvic varicose veins using AVP
Time frame: 24 months
39/5000 absence of symptoms and vaginal ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 41895652Yamamoto-Ramos M, De Gregorio MA, de Blas I, Sierre S, Urbano J, Mendez S, Abadal JM, Perez-Lafuente M, Aguirre N, Guirola JA. Understanding Recurrence in Pelvic Venous Disorders through the Symptoms-Varices-Pathophysiology Classification: A Multicenter Prospective Cohort Study. J Vasc Interv Radiol. 2026 Jul;37(7):108758. doi: 10.1016/j.jvir.2026.108758. Epub 2026 Mar 25.
- Individual participant dataSharing planned: No
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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.
Miguel A De Gregorio, Ph.D. principal investigator
Minimal Invasive Techniques Research Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Congestion Syndrome and Pelvic Varicose Veins, run by Group of Research in Minimally Invasive Techniques at 2 sites in Spain.
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 3 inclusion and 3 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 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Miguel A De Gregorio, Ph.D. (+34976765768, mgregori@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embolization of pelvic varicose veins using AVP (time frame: 24 months). 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 NCT04115137, 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 3 Oct 2019.