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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beda Hartmann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01436903
First received: August 12, 2011
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Menorrhagia
Device: Thermal Balloon Endometrial Ablation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Postsurgical change in bleeding patterns dependent on cavum probe length. [ Time Frame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. ] [ Designated as safety issue: No ]
    Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.

  • Postsurgical change in patient satisfaction dependent on cavum probe length. [ Time Frame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. ] [ Designated as safety issue: No ]
    The questionnaire will ask for satisfaction and recommendation to the best friend.


Secondary Outcome Measures:
  • Postsurgical change in dyspareunia [ Time Frame: A questionnaire will be sent in September 2010, at least after one postsurgical year. ] [ Designated as safety issue: No ]
    The questionnaire will ask for pre- and postsurgical dyspareunia.

  • Postsurgical change in Premenstrual Syndrome [ Time Frame: A questionnaire will be sent in September 2010, at least after one postsurgical year. ] [ Designated as safety issue: No ]
    The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.

  • Prevention of further gynaecological therapies [ Time Frame: A questionnaire will be sent in September 2010, at least after one postsurgical year. ] [ Designated as safety issue: No ]
    The questionnaire will ask for postsurgical hysterectomy and further medications.

  • Improvement of quality of life [ Time Frame: A questionnaire will be sent in September 2010, at least after one postsurgical year. ] [ Designated as safety issue: No ]
    The questionnaire will ask for postsurgical quality of life.


Enrollment: 290
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Thermal Balloon Endometrial Ablation
    Thermal Balloon Endometrial Ablation for 10 minutes after curettage
    Other Name: CavatermTM
  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436903

Locations
Austria
Landesklinikum Thermenregion Neunkirchen
Neunkirchen, Lower Austria, Austria, 2620
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Beda W. Hartmann, Univ.-Doz. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Beda Hartmann, Univ.-Doz. Dr. Mag., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01436903     History of Changes
Other Study ID Numbers: 743/2010
Study First Received: August 12, 2011
Last Updated: March 7, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
menorrhagia
dysfunctional uterine bleeding
endometrial ablation
cavatermTM
probe

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014