NCT03252041

Brief Summary

To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 14, 2017

Last Update Submit

August 14, 2017

Conditions

Pelvic Pain Syndrome

Keywords

PCS

Outcome Measures

Primary Outcomes (1)

  • MRI and MRV in pelvic congestion syndrome in females.

    To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

    one year

Interventions

MRIDEVICE

Magnetic Resonance imaging modalities and sequences in pelvic congestion syndrome

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIn the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome

You may qualify if:

  • All patients with signs and symptoms of PCS.

You may not qualify if:

  • Patients with general contraindications to MRI as presence of any para-magnetic substance as pacemakers, or in severely ill patients or those with claustrophobia, arrhythmic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hossam Galal, ass prof

    Assiut University, Egypt

    STUDY CHAIR

Central Study Contacts

Mohamed Sayed, (M.B.B.CH)

CONTACT

+201008253457dr.abudeif@gmail.com

Noha Attia, lect

CONTACT

+201001238435nohamohamedali@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 17, 2017

Study Start

September 1, 2017

Primary Completion

September 30, 2018

Study Completion

October 31, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08