Coil EmbolizationNCT05085938
Complications of Gonadal Veins Embolization
An observational study of Coil Embolization and Pelvic Venous Disorders, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
Gonadal veins embolization (GVE) with nitinol or platinum coils is widely used in the treatment of PeVD caused by the valvular incompetence of gonadal, parametrial, and uterine veins. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Coil Embolization, Pelvic Venous Disorders, Gonadal Veins Insufficiency
- What is being tested?
- gonadal vein embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2021to 20 May 2022
- 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 60 years
- Women only
- Adult
Study population: Cohort includes 150 women who have undergone gonadal vein embolisation or endoscopic resection
Who may be able to join
- the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities);
- reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography;
- gonadal veins embolization with coils.
Who cannot join
- the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography;
- open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Pirogov Russian National Research Medical University
Moscow
Oksana Efremova, PhD, +79168091193, lpl2@ya.ru
Sergey Gavrilov, MD, PhD
About this study
Official title: The Frequency of Complication and Their Causes After Gonadal Vein Embolization by Coils in Patients With Pelvic Venous Diseases
Gonadal veins embolization (GVE) with nitinol or platinum coils is widely used in the treatment of PeVD caused by the valvular incompetence of gonadal, parametrial, and uterine veins. Most authors report a high efficacy of this technique in reducing blood flow through the gonadal veins (GV) and relieving symptoms of the disease. In the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) guidelines, GVE is considered the standard of treatment for PeVD with a grade of recommendation 2B, due to the moderate quality of evidence. Moreover, other studies report about wide variability in the GVE outcomes, in terms of pelvic venous pain (PVP) elimination, persistence or intensification of pain after GVE, and coil migrations and protrusions. It is known that 6% to 32% of patients do not achieve significant pain relief after the procedure. The most studies of GVE in the treatment of PeVD are characterized by only a statement of the fact of any complication without investigating the causes of its development. At the same time, it is well known that it is a thorough study of complications that makes it possible to avoid failures in the future, to improve the therapeutic technique, or to abandon its use altogether.
In this study, it is planned to conduct a retrospective analysis of patients' database, who have undergone gonadal veins embolization with nitinol coils.
Read the detailed description
The aim of this study is to describe and study all side-effects and complications following embolization of gonadal veins.
This retrospective cohort study included 150 patients with PeVD who were treated by gonadal veins coil embolisation at the Savelyev University Surgical Clinic of the Pirogov Russian National Research Medical University in the period from 2000 to 2020. Patient informed consent was not required due to the retrospective nature of this study.
Inclusion criteria: the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities); reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography; and gonadal veins coil embolization.
Exclusion criteria: the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography; open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.
The diagnosis of PeVD was verified by transvaginal and transabdominal DUS, multiplanar computed tomographic venography, ovarian venography.
All patients who have undergone embolization of gonadal veins with coils were collected in a special database. The data includes parameters that can provoke complications, such as weight, duration of surgery and hospitalization, pain level before and after procedures, and others.
Gonadal vein embolization with coils:
GVE was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The vein puncture was performed under ultrasound guidance. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035" guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035" standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035" coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm. When selecting the coil size, the principle of 20% coil oversizing relative to the GV diameter was used in order to avoid coil migration in the conductive veins and pulmonary artery. After embolization, the control ovarian venography was performed.
Assessment of the gonadal vein embolization complications:
Complications of GVE were graded according to the Society for Interventional Radiology (SIR) Adverse Event Classification System as follows: A - No therapy, no consequences; B - Nominal therapy, no consequence; includes overnight admission for observation only; C - Requires therapy, minor hospitalization (< 48 h); D - Requires major therapy, unplanned increase in level of care, prolonged hospitalization (> 48 h); E - Permanent adverse sequelae; F - Death. Minor complications include classes A and B, and major complications include classes C to F.
Complications of gonadal vein embolization with coils included:
- Hematoma / bleeding at the access point;
- Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
- Postembolization syndrome;
- Protrusion of coils;
- Migration of coils;
- Allergic reactions to contrast agent or nickel. Complications of gonadal vein embolization with coils were assessed within 1-30 days and 12 month after procedure.
Primary Outcome Measure:
Change in the diameter of the pelvic veins
- The diameter of the pelvic veins was measured using duplex ultrasound. [Time Frame: At baseline and 1-12 months after pelvic vein intervention.]
- Change in the duration of pelvic venous reflux Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological.
[Time Frame: At baseline and 1-12 months after pelvic vein intervention.]
- Postprocedural pain The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results.
[Time Frame: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.] • Pelvic vein thrombosis Pelvic vein thrombosis was detected using duplex ultrasound. [Time Frame: 1 and 5 days after the intervention on the pelvic veins]
Other Pre-specified Outcome Measures:
- Complications of anesthesia Hematoma, vascular damage, pulmonary complications. [Time Frame: 1 and 5 days after the intervention on the pelvic veins]
- Conditions
- Coil Embolization, Pelvic Venous Disorders, Gonadal Veins Insufficiency, Pelvic Venous Pain
- Being tested
- gonadal vein embolization
- Keywords
- pelvic venous disorders, gonadal veins embolization, complication after coil embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gonadal vein embolizationProcedure or surgery
GVE was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035" guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035" standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035" coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm.
| Study group | Role | What they receive |
|---|---|---|
| Gonadal veins embolisation | This group includes patients who have undergone coil embolization of gonadal vein Receives: Procedure: gonadal vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the diameter of the pelvic veins
The diameter of the pelvic veins was measured using duplex ultrasound
Measured: At baseline and 1-12 months after pelvic vein intervention
Change in the duration of pelvic venous reflux
Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological
Measured: At baseline and 1-12 months after pelvic vein intervention
Postprocedural pain
The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results.
Measured: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins
Pelvic vein thrombosis
Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins). Pelvic vein thrombosis was detected using duplex ultrasound
Measured: 1 and 5 days after the intervention on the pelvic veins
Secondary outcomes (3)
Hemorrhagic complications
Hematoma or bleeding at the access poin
Measured: 1 and 5 days after the intervention on the pelvic veins
Other complications after embolisation
Protrusion or migration of coils
Measured: 1 day, 5 days, 1 and 12 months after coil embolization
Allergic reactions
Allergic reactions to contrast agent or nickel after procedure.
Measured: 1 day, 5 days, 1 and 12 months after coil embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start15 May 2021
- Primary completion20 Apr 2022 (estimated)
- Study completion20 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coil EmbolizationStudies 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085938
- Sponsor's protocol ID
- Co-GAVE
- Status last verified
- Sep 2021
- First submitted
- 7 Oct 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gavrilov SG, Krasavin GV, Mishakina NY, Efremova OI, Zolotukhin IA. The Effect of Venoactive Drug Therapy on the Development and Severity of Post-Embolization Syndrome in Endovascular Interventions on the Gonadal Veins. J Pers Med. 2021 Jun 7;11(6):521. doi: 10.3390/jpm11060521.
PubMed 34200127Gavrilov SG, Krasavin GV, Mishakina NY, Kirsanov KV. Postembolization syndrome in endovascular interventions on the gonadal veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):697-702. doi: 10.1016/j.jvsv.2020.09.003. Epub 2020 Sep 12.
PubMed 32932000Gavrilov SG, Sazhin A, Krasavin G, Moskalenko E, Mishakina N. Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):178-186. doi: 10.1016/j.jvsv.2020.05.013. Epub 2020 May 25.
PubMed 32464289
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Complication and Their Causes After Gonadal Vein Embolization by Coils in Patients With Pelvic Venous Diseases
- ClinicalTrials.gov ID
- NCT05085938
- Acronym / sponsor ID
- Co-GAVE
- Conditions
- Coil Embolization, Pelvic Venous Disorders, Gonadal Veins Insufficiency, Pelvic Venous Pain
- Keywords
- pelvic venous disorders, gonadal veins embolization, complication after coil embolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 20 Apr 2022 (estimated)
- Study completion
- 20 May 2022 (estimated)
- First posted
- 20 Oct 2021 (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.
Gonadal veins embolization (GVE) with nitinol or platinum coils is widely used in the treatment of PeVD caused by the valvular incompetence of gonadal, parametrial, and uterine veins. Most authors report a high efficacy of this technique in reducing blood flow through the gonadal veins (GV) and relieving symptoms of the disease. In the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) guidelines, GVE is considered the standard of treatment for PeVD with a grade of recommendation 2B, due to the moderate quality of evidence. Moreover, other studies report about wide variability in the GVE outcomes, in terms of pelvic venous pain (PVP) elimination, persistence or intensification of pain after GVE, and coil migrations and protrusions. It is known that 6% to 32% of patients do not achieve significant pain relief after the procedure. The most studies of GVE in the treatment of PeVD are characterized by only a statement of the fact of any complication without investigating the causes of its development. At the same time, it is well known that it is a thorough study of complications that makes it possible to avoid failures in the future, to improve the therapeutic technique, or to abandon its use altogether.
In this study, it is planned to conduct a retrospective analysis of patients' database, who have undergone gonadal veins embolization with nitinol coils.
Detailed description
The aim of this study is to describe and study all side-effects and complications following embolization of gonadal veins.
This retrospective cohort study included 150 patients with PeVD who were treated by gonadal veins coil embolisation at the Savelyev University Surgical Clinic of the Pirogov Russian National Research Medical University in the period from 2000 to 2020. Patient informed consent was not required due to the retrospective nature of this study.
Inclusion criteria: the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities); reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography; and gonadal veins coil embolization.
Exclusion criteria: the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography; open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.
The diagnosis of PeVD was verified by transvaginal and transabdominal DUS, multiplanar computed tomographic venography, ovarian venography.
All patients who have undergone embolization of gonadal veins with coils were collected in a special database. The data includes parameters that can provoke complications, such as weight, duration of surgery and hospitalization, pain level before and after procedures, and others.
Gonadal vein embolization with coils:
GVE was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The vein puncture was performed under ultrasound guidance. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035" guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035" standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035" coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm. When selecting the coil size, the principle of 20% coil oversizing relative to the GV diameter was used in order to avoid coil migration in the conductive veins and pulmonary artery. After embolization, the control ovarian venography was performed.
Assessment of the gonadal vein embolization complications:
Complications of GVE were graded according to the Society for Interventional Radiology (SIR) Adverse Event Classification System as follows: A - No therapy, no consequences; B - Nominal therapy, no consequence; includes overnight admission for observation only; C - Requires therapy, minor hospitalization (< 48 h); D - Requires major therapy, unplanned increase in level of care, prolonged hospitalization (> 48 h); E - Permanent adverse sequelae; F - Death. Minor complications include classes A and B, and major complications include classes C to F.
Complications of gonadal vein embolization with coils included:
- Hematoma / bleeding at the access point;
- Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
- Postembolization syndrome;
- Protrusion of coils;
- Migration of coils;
- Allergic reactions to contrast agent or nickel. Complications of gonadal vein embolization with coils were assessed within 1-30 days and 12 month after procedure.
Primary Outcome Measure:
Change in the diameter of the pelvic veins
- The diameter of the pelvic veins was measured using duplex ultrasound. [Time Frame: At baseline and 1-12 months after pelvic vein intervention.]
- Change in the duration of pelvic venous reflux Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological.
[Time Frame: At baseline and 1-12 months after pelvic vein intervention.]
- Postprocedural pain The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results.
[Time Frame: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.] • Pelvic vein thrombosis Pelvic vein thrombosis was detected using duplex ultrasound. [Time Frame: 1 and 5 days after the intervention on the pelvic veins]
Other Pre-specified Outcome Measures:
- Complications of anesthesia Hematoma, vascular damage, pulmonary complications. [Time Frame: 1 and 5 days after the intervention on the pelvic veins]
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gonadal veins embolisation | – | Procedure: gonadal vein embolizationThis group includes patients who have undergone coil embolization of gonadal vein |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Cohort includes 150 women who have undergone gonadal vein embolisation or endoscopic resection
Key inclusion criteria (3 listed)
- the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities);
- reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography;
- gonadal veins embolization with coils.
Key exclusion criteria (2 listed)
- the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography;
- open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.
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 |
|---|---|---|
| gonadal vein embolizationGVE was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035" guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035" standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035" coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm. | Procedure or surgery | Gonadal veins embolisation |
Primary outcome
Change in the diameter of the pelvic veins
Time frame: At baseline and 1-12 months after pelvic vein intervention
The diameter of the pelvic veins was measured using duplex ultrasound
Change in the duration of pelvic venous reflux
Time frame: At baseline and 1-12 months after pelvic vein intervention
Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological
Postprocedural pain
Time frame: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins
The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results.
Pelvic vein thrombosis
Time frame: 1 and 5 days after the intervention on the pelvic veins
Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins). Pelvic vein thrombosis was detected using duplex ultrasound
3 secondary outcomes
Hemorrhagic complications
Time frame: 1 and 5 days after the intervention on the pelvic veins
Other complications after embolisation
Time frame: 1 day, 5 days, 1 and 12 months after coil embolization
Allergic reactions
Time frame: 1 day, 5 days, 1 and 12 months after coil embolization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 34200127Gavrilov SG, Krasavin GV, Mishakina NY, Efremova OI, Zolotukhin IA. The Effect of Venoactive Drug Therapy on the Development and Severity of Post-Embolization Syndrome in Endovascular Interventions on the Gonadal Veins. J Pers Med. 2021 Jun 7;11(6):521. doi: 10.3390/jpm11060521.
- Background: PubMed 32932000Gavrilov SG, Krasavin GV, Mishakina NY, Kirsanov KV. Postembolization syndrome in endovascular interventions on the gonadal veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):697-702. doi: 10.1016/j.jvsv.2020.09.003. Epub 2020 Sep 12.
- Background: PubMed 32464289Gavrilov SG, Sazhin A, Krasavin G, Moskalenko E, Mishakina N. Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):178-186. doi: 10.1016/j.jvsv.2020.05.013. Epub 2020 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coil Embolization and Pelvic Venous Disorders, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 2 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 Feb 2022. 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 Russia. 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 Sergey Gavrilov, MD, PhD (+79168091193, lpl2@ya.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the diameter of the pelvic veins (time frame: At baseline and 1-12 months after pelvic vein intervention). The study lists 4 primary outcomes in all. 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 NCT05085938, which also lists 3 linked publications.
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 Feb 2022.