Pelvic Congestive SyndromeNCT03165214
Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
A study testing coil and hystoacryl glue in people with Pelvic Congestive Syndrome, run by Assiut University at 2 sites in Egypt.
Trial summary
Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Pelvic Congestive Syndrome
- What is being tested?
- coil and hystoacryl glue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2017to Sep 2019
- Phase
- Interventional
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical symptoms of pelvic congestion syndrome documented by Doppler ultrasound
- Failed medical treatment.
Who cannot join
- Endometriosis.
- Uterine fibroids.
- Previous pelvic operations.
- Urological diseases.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ahmed Abbas
Assiut, Cairo Governorate, 002
Assiut Faculty of Medicine
Asyut
About this study
Official title: Effectiveness of Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain. In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome and is an important but under-diagnosed condition
- Conditions
- Pelvic Congestive Syndrome
- Being tested
- coil, hystoacryl glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coilDevice
microcoils
hystoacryl glueDevice
hystoacryl mixed with lipidol
| Study group | Role | What they receive |
|---|---|---|
| coil group | Active comparator | micro coils Receives: Device: coil |
| glue group | Experimental | hystoacryl mixed with lipidol Receives: Device: hystoacryl glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of treated patients with different interventions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jul 2017
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestive SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165214
- Sponsor's protocol ID
- PCS
- Status last verified
- Aug 2020
- First submitted
- 23 May 2017
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT03165214
- Acronym / sponsor ID
- PCS
- Conditions
- Pelvic Congestive Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 May 2017 (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.
Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain. In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome and is an important but under-diagnosed condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coil group | Active comparator | Device: coilmicro coils |
| glue group | Experimental | Device: hystoacryl gluehystoacryl mixed with lipidol |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical symptoms of pelvic congestion syndrome documented by Doppler ultrasound
- Failed medical treatment.
Key exclusion criteria (4 listed)
- Endometriosis.
- Uterine fibroids.
- Previous pelvic operations.
- Urological diseases.
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 |
|---|---|---|
| coilmicrocoils | Device | coil group |
| hystoacryl gluehystoacryl mixed with lipidol | Device | glue group |
Primary outcome
The number of treated patients with different interventions
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coil and hystoacryl glue in people with Pelvic Congestive Syndrome, run by Assiut University at 2 sites in Egypt.
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 2 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: withdrawn, as of the sponsor's last update on 12 Aug 2020. 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 Egypt. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The number of treated patients with different interventions (time frame: 6 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 12 Aug 2020.