The purpose of the study is to evaluate the effectiveness and acceptability of the hot fluid balloon endometrial Thermablate ablation system compared with the Bipolar RF Novasure ablation treatment performed in an outpatient setting in eliminating…
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective Evaluate the effectiveness of Device procedure compared to
in achieving amenorrhea at twelve months post-treatment for menorrhagia
secondary to DUB
Secondary outcome
Evaluate and compare pain and acceptability scores of the hot fluid balloon
ablation (Thermablate) procedure and the Novasure Endometrial Ablation
procedure as an outpatient treatment.
Background summary
Since 1994 a lot of blind, disposable endometrial ablation devices have been
developed. One of these is the Novasure ablation technique which uses
RF-currency. This technique has been proven effective (Bongers 2004, Kleijn
2008). Recently this technique has been performed under local anesthesia in the
outpatient clinic. The Thermablate ablation technique is relatively new on the
market. It is a balloon technique with a small diameter and short treatment
time. Theoretically it seems perfect for an outpatient treatment under local
anesthesia.
Study objective
The purpose of the study is to evaluate the effectiveness and acceptability of
the hot fluid balloon endometrial Thermablate ablation system compared with the
Bipolar RF Novasure ablation treatment performed in an outpatient setting in
eliminating menorrhagia secondary to dysfunctional uterine bleeding in women
who no longer wish to retain fertility
Study design
RCT 1:1 randomisation
Intervention
Novasure Global endometrial ablation
Thermablate endometrial ablation
Study burden and risks
No extra risk for the patient in comparison with endometrial treatment outside
the trial.
Only 25 minutes of time necessary for interview lists and the painscore
de Run 4600
5500 MB, Veldhoven
Nederland
de Run 4600
5500 MB, Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Refractory menorraghia ;Uterine sound measurement of 6.0 - 12 cm ;Failed, contraindicated or intolerance to conservative therapy. ;Menstrual Diary A minimum score of >150 for 1 months ;Willing to undergo the treatment under local anesthesia in the outpatient clinic
Exclusion criteria
3.2.2.1 Presence of bacteremia, sepsis, or other active systemic infection;3.2.2.2 Active or recurrent chronic pelvic inflammatory disease ;3.2.2.3 Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g., transmural myomectomy or classical cesarean section. Prior endometrial ablations.;3.2.2.4 Desire to preserve fertility ;3.2.2.5 Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) ;3.2.2.6 Suspected or confirmed uterine malignancy or confirmed uterine malignancy within the last five years as confirmed by histology );3.2.2.7 Endometrial hyperplasia as confirmed by histology ;3.2.2.8 Unaddressed cervical dysplasia;3.2.2.9 Elevated FSH levels consistent with ovarian failure ( > 40 IU/ml) ;3.2.2.10 Active sexually transmitted disease
Design
Recruitment
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 | NL22264.015.08 |