NCT03165214

Brief 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. In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome and is an important but under-diagnosed condition

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

May 23, 2017

Last Update Submit

August 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of treated patients with different interventions

    6 months

Study Arms (2)

coil group

ACTIVE COMPARATOR

micro coils

Device: coil

glue group

EXPERIMENTAL

hystoacryl mixed with lipidol

Device: hystoacryl glue

Interventions

coilDEVICE

microcoils

coil group

hystoacryl mixed with lipidol

glue group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical symptoms of pelvic congestion syndrome documented by Doppler ultrasound
  • Failed medical treatment.

You may not qualify if:

  • Endometriosis.
  • Uterine fibroids.
  • Previous pelvic operations.
  • Urological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Assiut Faculty of Medicine

Asyut, Egypt

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations