Role of Uterine Artery Embolization in Adenomyosis
Primary Purpose
Adenomyosis
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Trans-arterial uterine artery embolization
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis
Eligibility Criteria
Inclusion Criteria:
- Symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
females with adenomyosis
Arm Description
Outcomes
Primary Outcome Measures
uterine artery embolization in management of adenomyosis
study the effect of embolization on symptoms and imaging findings
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597644
Brief Title
Role of Uterine Artery Embolization in Adenomyosis
Official Title
Role of Uterine Artery Angioembolization in Management of Uterine Adenomyosis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Adenomyosis is defined by the abnormal location of endometrial tissue within the myometrium associated with hypertrophy or hyperplasia of the myometrial stroma. Although pathogenesis and etiology of adenomyosis remain unknown, two main theories have been proposed: invagination of the endometrial basal layer and metaplasia of embryonic stem cells. Despite the absence of specific (pathognomonic) diagnostic features for uterine adenomyosis, typical symptoms include menorrhagia, chronic pelvic pain, and dysmenorrhea.
For more than a century, diagnosis was dependent on histopathologic examination of post-hysterectomy specimens till the introduction of noninvasive ultrasound and MR techniques. Since then, several studies have illustrated high sensitivities and specificities for both two-dimensional transvaginal sonography (TVS) and magnetic resonance imaging (MRI). Current treatment options for symptomatic adenomyosis include hysterectomy, medication, conservative surgery, or minimally invasive techniques including uterine artery embolization. To date, hysterectomy remains the definitive treatment. This is mainly due to difficult diagnosis, the diffuse nature of the disease, and little evidence-based literature needed to standardize treatments. This consequently results in a management dilemma, particularly in symptomatic patients who wish to preserve their uterus.
Uterine artery embolization is the use of transarterial catheters aiming to induce more than 34% necrosis within adenomyotic tissues. Vascular access is gained through a femoral or radial artery puncture using 4-6-French (F) arterial sheath for femoral and 4-F sheath for radial access. Under fluoroscopic guidance, aortography is followed by selective and super selective arteriography using 4-5-F catheters for the internal iliac and 2-3-F microcatheters for the uterine artery and its branches respectively. Embolization is usually performed using variable-sized permanent particulate agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Angioembolization of uterine artery by PVA particles
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
females with adenomyosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Trans-arterial uterine artery embolization
Intervention Description
transarterial angioembolization of uterine artery
Primary Outcome Measure Information:
Title
uterine artery embolization in management of adenomyosis
Description
study the effect of embolization on symptoms and imaging findings
Time Frame
baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moustafa Al-Hussaini, Specialist
Phone
01023646463
Email
moustafa71989@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Refaat, Lecturer
Phone
01003133736
Email
mahmoud.abdelzaher@med.au.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab Mansour, Assistant Professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abd ElKareem Hasan, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Role of Uterine Artery Embolization in Adenomyosis
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