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

NCT01436903 | Completed Phase 4

• 1 other identifier: 743/2010
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia

Keywords

menorrhagia; dysfunctional uterine bleeding; endometrial ablation; cavatermTM; probe

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (4)

• Postsurgical change in dyspareunia

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

• Postsurgical change in Premenstrual Syndrome

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

• Prevention of further gynaecological therapies

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

• Improvement of quality of life

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

Interventions

Thermal Balloon Endometrial Ablation DEVICE

Thermal Balloon Endometrial Ablation for 10 minutes after curettage

Also known as: CavatermTM

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• CavatermTM operation because of menorrhagia
• timeframe: January 2006 till August 2009
• older than 29 years and younger than 56 years

You may not qualify if:

• pregnancy
• fragmentary filled questionnaire
• more than 1 CavatermTM operation

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Landesklinikum Thermenregion Neunkirchen

Neunkirchen, Lower Austria, 2620, Austria

Location

MeSH Terms

Conditions

Menorrhagia; Metrorrhagia

Condition Hierarchy (Ancestors)

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

Study Officials

• Beda W. Hartmann, Univ.-Doz.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Doz. Dr. Mag.

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: September 20, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

AU (1)