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Completed

NCT Number: NCT01436903

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

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Landesklinikum Thermenregion Neunkirchen

Neunkirchen, Lower Austria, 2620, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal Balloon Endometrial Ablation

Device

Thermal Balloon Endometrial Ablation for 10 minutes after curettage

Other names: CavatermTM

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Postsurgical change in dyspareunia

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: A questionnaire will be sent in September 2010, at least after one postsurgical year.

    The questionnaire will ask for postsurgical quality of life.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2011
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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