Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Menorrhagia

Treatments: Device: Thermal Balloon Endometrial Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01436903

743/2010

Details and patient eligibility

About

CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.

Enrollment: 290 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CavatermTM operation because of menorrhagia
• timeframe: January 2006 till August 2009
• older than 29 years and younger than 56 years

Exclusion criteria

• pregnancy
• fragmentary filled questionnaire
• more than 1 CavatermTM operation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)