Pelvic Congestion SyndromeNCT02796092
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
A study testing Fibered platinum coils and Vascular plugs in people with Pelvic Congestion Syndrome, run by Group of Research in Minimally Invasive Techniques at 1 site in Spain.
Trial summary
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Congestion Syndrome
- What is being tested?
- Fibered platinum coils and Vascular plugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Presence of chronic abdominal or pelvic pain for more than 6 months
- >6 mm pelvic venous caliber measured by transvaginal US
- Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US
Who cannot join
- Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma
- Glomerular filtration rate <60 ml/min
- History of contrast reaction
- Patients not able to be followed up for at least one year
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.
Read the detailed description
This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).
- Conditions
- Pelvic Congestion Syndrome
- Being tested
- Fibered platinum coils, Vascular plugs
- Keywords
- Pelvic Congestion Syndrome, Pelvic Venous Insufficiency, Chronic pelvic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibered platinum coilsDevice
Also called Nester coils
Vascular plugsDevice
Also called Amplatzer vascular plugs
| Study group | Role | What they receive |
|---|---|---|
| Fibered platinum coils | Active comparator | Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Receives: Device: Fibered platinum coils |
| Vascular plugs | Experimental | Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Receives: Device: Vascular plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scale
Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).
VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)
Measured: 12 months
Secondary outcomes (13)
Improvement of Dyspareunia
Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Measured: 12 months
Improvement of Urinary Urgency
Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Measured: 12 months
Improvement of Dysmenorrhea
Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Measured: 12 months
Satisfaction With the Procedure
Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).
Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem.
Measured: 12 months
Number of Devices Used
Number of coils and number of vascular plugs used in each procedure
Measured: intraoperative
Cost of Treatment
Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.
Measured: Intraoperative
Total Intervention Duration
Total time length of the procedure, from puncture to compression (in minutes)
Measured: Intraoperative
Fluoroscopy Time
Total fluoroscopy time, recorded by the equipment (in minutes)
Measured: Intraoperative
Procedure Radiation Dose (DAP)
DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment
Measured: Intraoperative
Procedure Radiation Dose (AK)
AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment
Measured: Intraoperative
Complications
Total number of events during the procedure
Measured: intraoperative
Complications
Toral number of events related to the procedure in the follow-up (1 year)
Measured: 12 months
Need for Re-embolization
Scheduled re-embolization due to incomplete occlusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
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, MD, PhD, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796092
- Sponsor's protocol ID
- GTM-01
- Status last verified
- Feb 2017
- First submitted
- 27 May 2016
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT02796092
- Acronym / sponsor ID
- GTM-01
- Conditions
- Pelvic Congestion Syndrome
- Keywords
- Pelvic Congestion Syndrome, Pelvic Venous Insufficiency, Chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Group of Research in Minimally Invasive TechniquesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Posted 26 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.
Detailed description
This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibered platinum coils | Active comparator | Device: Fibered platinum coilsEmbolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) |
| Vascular plugs | Experimental | Device: Vascular plugsEmbolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Presence of chronic abdominal or pelvic pain for more than 6 months
- >6 mm pelvic venous caliber measured by transvaginal US
- Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US
Key exclusion criteria (4 listed)
- Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma
- Glomerular filtration rate <60 ml/min
- History of contrast reaction
- Patients not able to be followed up for at least one year
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 |
|---|---|---|
| Fibered platinum coilsAlso: Nester coils | Device | Fibered platinum coils |
| Vascular plugsAlso: Amplatzer vascular plugs | Device | Vascular plugs |
Primary outcome
Change in Pain Scale
Time frame: 12 months
Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)
13 secondary outcomes
Improvement of Dyspareunia
Time frame: 12 months
Improvement of Urinary Urgency
Time frame: 12 months
Improvement of Dysmenorrhea
Time frame: 12 months
Satisfaction With the Procedure
Time frame: 12 months
Number of Devices Used
Time frame: intraoperative
Cost of Treatment
Time frame: Intraoperative
Total Intervention Duration
Time frame: Intraoperative
Fluoroscopy Time
Time frame: Intraoperative
Procedure Radiation Dose (DAP)
Time frame: Intraoperative
Procedure Radiation Dose (AK)
Time frame: Intraoperative
Complications
Time frame: intraoperative
Complications
Time frame: 12 months
Need for Re-embolization
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, MD, PhD principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibered platinum coils and Vascular plugs in people with Pelvic Congestion Syndrome, run by Group of Research in Minimally Invasive Techniques at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 26 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2017.