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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01436903
Collaborator
(none)
290
Enrollment
1
Location
7
Duration (Months)
41.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Thermal Balloon Endometrial Ablation
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
290 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Postsurgical change in bleeding patterns dependent on cavum probe length. [Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.]

    Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.

  2. Postsurgical change in patient satisfaction dependent on cavum probe length. [Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.]

    The questionnaire will ask for satisfaction and recommendation to the best friend.

Secondary Outcome Measures

  1. Postsurgical change in dyspareunia [A questionnaire will be sent in September 2010, at least after one postsurgical year.]

    The questionnaire will ask for pre- and postsurgical dyspareunia.

  2. Postsurgical change in Premenstrual Syndrome [A questionnaire will be sent in September 2010, at least after one postsurgical year.]

    The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.

  3. Prevention of further gynaecological therapies [A questionnaire will be sent in September 2010, at least after one postsurgical year.]

    The questionnaire will ask for postsurgical hysterectomy and further medications.

  4. Improvement of quality of life [A questionnaire will be sent in September 2010, at least after one postsurgical year.]

    The questionnaire will ask for postsurgical quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beda Hartmann, Univ.-Doz. Dr. Mag., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01436903
Other Study ID Numbers:
  • 743/2010
First Posted:
Sep 20, 2011
Last Update Posted:
Mar 8, 2013
Last Verified:
Mar 1, 2013
Keywords provided by Beda Hartmann, Univ.-Doz. Dr. Mag., Medical University of Vienna
menorrhagia
dysfunctional uterine bleeding
endometrial ablation
cavatermTM
probe
Additional relevant MeSH terms:
Menorrhagia

Study Results

No Results Posted as of Mar 8, 2013