Endometrial Tissue Ablation, a clinical trial. Hydrotherm vs. Novasure

Endometrial Tissue Ablation, a clinical trial. Hydrotherm vs. Novasure - Endometrial Tissue Ablation, a clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30019

Enrollment

200

Registered

2006-10-16

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heavy menstruation hypermenorrhoea

Interventions

HydroThermAblation or Novasure ablation of endometrial tissue. HydroThermaAblation system uses hot saline ablation under direct hysteroscopic view. Novasure consists of a 3-dimensional bipolar imped

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Dysfunctional uterine bleeding Uterine sound measurements of 6.0-12.0 cm Failed, contraindicated or intolerance to conservative (medical) therapy

Exclusion criteria

Exclusion criteria: Desire to have children or preserve fertility Abnormal/ obstructed uterine cavity

Design outcomes

Primary

Measure	Time frame
Quality of life, measured by questionnaires filled in by the patient pre-operative, 4 weeks, 6 and 12 months after treatment. Questionnaires contain Short Form 36 and a structured clinical history questionnaire. Patients satisfaction is measured by using a visual analogue scale.	—

Secondary

Measure	Time frame
Amenorrhoea. Using a pictorial chart in every questionnaire.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)