Back to resultsChances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
Primary Purpose
Menorrhagia
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Thermal Balloon Endometrial Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring menorrhagia, dysfunctional uterine bleeding, endometrial ablation, cavatermTM, probe
Eligibility Criteria
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
Sites / Locations
- Landesklinikum Thermenregion Neunkirchen
Outcomes
Primary Outcome Measures
Postsurgical change in bleeding patterns dependent on cavum probe length.
Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.
Postsurgical change in patient satisfaction dependent on cavum probe length.
The questionnaire will ask for satisfaction and recommendation to the best friend.
Secondary Outcome Measures
Postsurgical change in dyspareunia
The questionnaire will ask for pre- and postsurgical dyspareunia.
Postsurgical change in Premenstrual Syndrome
The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.
Prevention of further gynaecological therapies
The questionnaire will ask for postsurgical hysterectomy and further medications.
Improvement of quality of life
The questionnaire will ask for postsurgical quality of life.
Full Information
NCT ID
NCT01436903
First Posted
August 12, 2011
Last Updated
March 7, 2013
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01436903
Brief Title
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
Official Title
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
menorrhagia, dysfunctional uterine bleeding, endometrial ablation, cavatermTM, probe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Thermal Balloon Endometrial Ablation
Other Intervention Name(s)
CavatermTM
Intervention Description
Thermal Balloon Endometrial Ablation for 10 minutes after curettage
Primary Outcome Measure Information:
Title
Postsurgical change in bleeding patterns dependent on cavum probe length.
Description
Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.
Time Frame
Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Title
Postsurgical change in patient satisfaction dependent on cavum probe length.
Description
The questionnaire will ask for satisfaction and recommendation to the best friend.
Time Frame
Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Secondary Outcome Measure Information:
Title
Postsurgical change in dyspareunia
Description
The questionnaire will ask for pre- and postsurgical dyspareunia.
Time Frame
A questionnaire will be sent in September 2010, at least after one postsurgical year.
Title
Postsurgical change in Premenstrual Syndrome
Description
The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.
Time Frame
A questionnaire will be sent in September 2010, at least after one postsurgical year.
Title
Prevention of further gynaecological therapies
Description
The questionnaire will ask for postsurgical hysterectomy and further medications.
Time Frame
A questionnaire will be sent in September 2010, at least after one postsurgical year.
Title
Improvement of quality of life
Description
The questionnaire will ask for postsurgical quality of life.
Time Frame
A questionnaire will be sent in September 2010, at least after one postsurgical year.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beda W. Hartmann, Univ.-Doz.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landesklinikum Thermenregion Neunkirchen
City
Neunkirchen
State/Province
Lower Austria
ZIP/Postal Code
2620
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
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