NCT05597644

Brief Summary

Management of symptomatizing women diagnosed with uterine adenomyosis, by uterine artery angioembolization as a minimally invasive replacement for hysterectomy. This is followed by assessment of the symptoms and MRI of the pelvis after 3 months.

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
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2023

Typical duration for early_phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 28, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

October 25, 2022

Last Update Submit

October 25, 2022

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (1)

  • uterine artery embolization in management of adenomyosis

    study the effect of embolization on symptoms and imaging findings

    baseline

Study Arms (1)

females with adenomyosis

EXPERIMENTAL
Procedure: Trans-arterial uterine artery embolization

Interventions

Trans-arterial uterine artery embolizationPROCEDURE

transarterial angioembolization of uterine artery

females with adenomyosis

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy.

You may not qualify if:

  • Women who desire further child bearing (not completed their family yet).
  • Impaired coagulation profile.
  • Hypersensitivity to intravenous contrast media.
  • Decompensated congestive heart failure.
  • Hypertensive crisis.
  • Stroke or CVA.
  • Renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ehab Mansour, Assistant Professor

    Assiut University

    STUDY DIRECTOR

  • Abd ElKareem Hasan, Professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Moustafa Al-Hussaini, Specialist

CONTACT

01023646463moustafa71989@gmail.com

Mahmoud Refaat, Lecturer

CONTACT

01003133736mahmoud.abdelzaher@med.au.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Angioembolization of uterine artery by PVA particles
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

January 1, 2023

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

October 28, 2022

Record last verified: 2022-05