SAFE: Sequre for Adenomyosis and Fibroid Embolisatio

Withdrawn

Conditions: uterus fibroids and adenomyosis
10038595
10013326
10003184

Registration Number: NL-OMON52676

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- premenopausal woman, age > 30yrs and <= 55yrs
- pure adenomyosis, uterine leiomyomata or adenomyosis dominancy with fibroids
clinically
diagnosed and confirmed with MR imaging.
- symptoms e.g. heavy menstrual bleeding, pelvic pain, and bulk related
symptoms.
- written informed consent.

Exclusion Criteria

- fibroid >= 5 cm
- pregnancy
- seeking future pregnancy
- presence or suspicion of any gynaecologic malignancy
- presence or suspicion of any pelvic inflammatory disease
- pelvic congestion syndrome
- already infarcted / calcified leiomyomata
- bleeding disorder
- renal function disorder

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>QOL scores and MRI (the difference in volume) are the two main study<br /><br>endpoints. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study endpoints are:<br /><br>- Number vials / ml particles used (+ size)<br /><br>- Number of protection coils used to avoid advert side branch non target<br /><br>embolization<br /><br>- Complications<br /><br>- Imaging post-procedure at 3 month follow up MRI: % necrosis<br /><br>(infarction 100% - 95- 100% or <95%)<br /><br>- Procedure time<br /><br>- Radiation exposure<br /><br>- Peri-procedural pain (defined by analgesics administered) </p><br>