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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 25, 2022
    Last Updated
    October 25, 2022
    Sponsor
    Assiut University
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    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

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    Role of Uterine Artery Embolization in Adenomyosis

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