Endometrial Ablation With Non-hysteroscopic Methods

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Dysfunctional Uterine Bleeding

Treatments: Device: Novasure; Device: MEA

Study type: Interventional

Funder types: Other

Identifiers

NCT01173965

3873

Details and patient eligibility

About

Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.

Enrollment: 66 patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)

Exclusion criteria

• Endometrial pathology
• FSH > 20 day 2 -day 3 of the cycle
• Clotting Disorders
• Thyroid Dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Endometrial ablation with microwaves

Active Comparator group

Description:

Endometrial ablation with the use of MEA(microwaves endometrial ablation device)

Treatment:

Device: MEA

Endometrial ablation with bipolar diathermy

Active Comparator group

Description:

Endometrial ablation with Novasure(bipolar impedence control system)

Treatment:

Device: Novasure