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

Menorrhagia Clinical Trial

Official title:

Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436903
• Other study ID #: 743/2010
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2011
• Last updated: March 7, 2013
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• Thermal Balloon Endometrial Ablation
Thermal Balloon Endometrial Ablation for 10 minutes after curettage

Locations

Country	Name	City	State
Austria	Landesklinikum Thermenregion Neunkirchen	Neunkirchen	Lower Austria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postsurgical change in bleeding patterns dependent on cavum probe length.	Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.	Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.	No
Primary	Postsurgical change in patient satisfaction dependent on cavum probe length.	The questionnaire will ask for satisfaction and recommendation to the best friend.	Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.	No
Secondary	Postsurgical change in dyspareunia	The questionnaire will ask for pre- and postsurgical dyspareunia.	A questionnaire will be sent in September 2010, at least after one postsurgical year.	No
Secondary	Postsurgical change in Premenstrual Syndrome	The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.	A questionnaire will be sent in September 2010, at least after one postsurgical year.	No
Secondary	Prevention of further gynaecological therapies	The questionnaire will ask for postsurgical hysterectomy and further medications.	A questionnaire will be sent in September 2010, at least after one postsurgical year.	No
Secondary	Improvement of quality of life	The questionnaire will ask for postsurgical quality of life.	A questionnaire will be sent in September 2010, at least after one postsurgical year.	No