The aim of this research is to test the efficacy and safety of a new microcatheter 2.8F Sequre for treatment of uterine fibroids and/or adenomyosis with a standard embolization technique and to demonstrate the added value of this catheter, namely to…
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Menstrual cycle and uterine bleeding disorders
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
QOL scores and MRI (the difference in volume) are the two main study
endpoints.
Secondary outcome
The secondary study endpoints are:
- Number vials / ml particles used (+ size)
- Number of protection coils used to avoid advert side branch non target
embolization
- Complications
- Imaging post-procedure at 3 month follow up MRI: % necrosis
(infarction 100% - 95- 100% or <95%)
- Procedure time
- Radiation exposure
- Peri-procedural pain (defined by analgesics administered)
Background summary
Uterine fibroid and adenomyosis embolization (UAE) is currently accepted as an
alternative to uterine removal (hysterectomy) or to surgically remove fibroids
(myomectomy) or adenomyosis in women who have symptoms such as: heavy menstrual
bleeding, pain and other symptoms due to the presence of uterine fibroids or
adenomyosis. Many women appreciate the results achieved with embolization:
improvement or elimination of symptoms and reduction of the size of the
fibroids or adenomyosis while preserving the uterus and preserving fertility.
Despite these good results, there is still a belief that fibroid embolization
can be improved by using a different type of catheter, the 2.8F Sequre catheter.
The feature of this catheter is that, due to its special size, it significantly
reduces the risk of (partial) embolization of surrounding tissue.
The expected result of this study is to demonstrate that, using the 2.8F
catheter, there is less unnecessary damage to the surrounding tissue compared
to standard fibroid embolization.
Study objective
The aim of this research is to test the efficacy and safety of a new
microcatheter 2.8F Sequre for treatment of uterine fibroids and/or adenomyosis
with a standard embolization technique and to demonstrate the added value of
this catheter, namely to reduce the possible risks compared to a standard
catheter. The effectiveness of the catheter is examined. It is compared with
the results of embolisations previously performed (retrospective status study)
to eliminate the fibroids and/or adenomyosis. Also, the special size of the
2.8F Sequre catheter can help accelerate embolization with more embolate
directly to the fibroid and/or adenomyosis and less embolate to surrounding
tissue.
Study design
The Safe study is a single-center, prospective, cohort trial.
Intervention
Embolization of myomas and/or adenomyosis (UAE) with the microcatheter 2.8F,
performed by experienced intervention radiologists.
Results are compared with retrospective status studies.
Study burden and risks
-MRI before embolization including questionnaire/ visit gynaecologist and blood
sample (partly standard care)
-Fibroid or/and adenomyosis embolization
-MRI 3 months after embolization including questionnaire, visit radiologist
(standard -care), and blood sample (not standard care)
- questionnaire contains question 'ethnicity'
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74393.028.21 |