NCT03535610

Brief Summary

To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

May 14, 2018

Last Update Submit

September 3, 2020

Conditions

Uterine Leiomyoma

Keywords

EmbolizationUterine LeiomyomaEmbospheresMicrospheres

Outcome Measures

Primary Outcomes (2)

  • Uterine Volume Reduction

    Uterine Volume Reduction measured by MRI

    6 months

  • Fibroid Reduction

    Fibroid Reduction measured by MRI

    6 months

Secondary Outcomes (2)

  • Quality of Life Improvement

    6 months

  • Ovarian Function

    6 months

Study Arms (1)

Embolization

EXPERIMENTAL

Uterine Embolization with PVA Microspheres

Device: Uterine Embolization

Interventions

Uterine EmbolizationDEVICE

Uterine Embolization with PVA Microspheres

Embolization

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with Uterine Leiomyoma
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female patients from 18 to 50 years old;
  • symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
  • patient agrees with study procedures;
  • patient signs the informed consent form.

You may not qualify if:

  • asymptomatic women;
  • isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
  • leiomyoma diameter higher than 10 cm;
  • leiomyoma above the umbilical scar;
  • endometrial neoplasia or hyperplasia or presence of any malignancy
  • pregnant or breast feeding women;
  • active vasculitis;
  • pelvic irradiation history;
  • uncontrolled coagulopathies;
  • renal insufficiency;
  • contrast allergy;
  • concomitant use of GnRH analogues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Certa Centro de Referência em Tratamentos Avançados

São Paulo, São Paulo, 01401-002, Brazil

Location

MeSH Terms

Conditions

Myofibroma

Interventions

Uterine Artery Embolization

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Embolization, TherapeuticHemostatic TechniquesTherapeuticsTherapeutic OcclusionGynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-arm, open label study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

August 13, 2018

Primary Completion

February 20, 2020

Study Completion

May 20, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)