NCT03943381

Brief Summary

To investigate the feasibility of Duplex US 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 May 2019

Shorter than P25 for all trials

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

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 9, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

May 7, 2019

Last Update Submit

May 8, 2019

Conditions

Keywords

PCS

Outcome Measures

Primary Outcomes (1)

  • Duplex US in Pelvic Congestion Syndrome in females

    to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome

    6 months

Interventions

Duplex USDEVICE

Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). 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 VolunteersYes
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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hossam M Galal

    Assiut University, Egypt

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

May 10, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

May 9, 2019

Record last verified: 2019-04