NCT00549159

Brief Summary

The purpose of study is to compare the treatment success in the study groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

2 years

First QC Date

October 24, 2007

Last Update Submit

May 19, 2008

Conditions

Dysfunctional Uterine Bleeding

Keywords

menorrhagiadysfunctional uterine bleedingendometrial ablation

Outcome Measures

Primary Outcomes (1)

  • Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75

    12 months

Secondary Outcomes (1)

  • SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment

    12 months

Study Arms (2)

Cavaterm

EXPERIMENTAL
Device: Thermal Balloon Endometrial Ablation

TCRE

ACTIVE COMPARATOR

Transcervical resection of the endometrium

Device: Transcervical Resection of the Endometrium

Interventions

Thermal Balloon Endometrial AblationDEVICE

Thermal balloon endometrial ablation

Cavaterm
Transcervical Resection of the EndometriumDEVICE

Transcervical resection of the endometrium

TCRE

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Willingness and adequate mental capacity to sign written, informed consent
  • Willingness to adhere to study plan regarding control visits and recording of PBLAC
  • \> 30 years old
  • Pre-menopausal as determined by FSH ≤30
  • Agree not to use hormonal contraception or any other intervention for bleeding during study
  • Suitable for local and/or general anesthesia
  • A minimum PBLAC score of ≥ 150 for three months prior to study enrollment; OR PBLAC score 150 for one month for women who 1) had at least 3 (documented) prior months of failed medical therapy; 2) had a contraindication to medical therapy; or 3) refused medical therapy
  • Uterine cavity sound measurement ≥ 4 cm and ≤ 10 cm.

You may not qualify if:

  • Presence of bacteriaemia, sepsis, or other active systemic infection
  • Active pelvic inflammatory disease
  • Clotting defects or bleeding disorders
  • Unwillingness to use a non-hormonal birth control post-ablation
  • Desire for future fertility
  • Abnormal cavity as confirmed by hysteroscopy, transvaginal ultrasound or HSG e.g. large fibroids, septum etc. Small submucosal fibroids defined as \< 2 cm are in this context not considered abnormal.
  • Any condition leading to possible uterine wall weakness with total wall thickness \< 15 mm e.g. at c.section, postmyomectomy scars etc. In case of uniform uterine wall the wall thickness at the fundus should be measured.
  • Premalignant or malignant uterine condition within the last five years as confirmed by histology
  • Pregnancy
  • Cervical length \> 6 cm.
  • Uterine cavity \>30 ml defined as balloon can be filled with 30ml glucose solution without reaching the target pressure of 240 mmHg. (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately. The patients will be recorded as screening failures).
  • Previous ablation or subtotal hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhu Jiang Hospital

Guangzhou, Guangdong, 510282, China

RECRUITING

Guangzhou Southern Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

MetrorrhagiaMenorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Yanhong Yu, Prof.

    Guangzhou Southern Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhong Yu, Prof.

CONTACT

+862061641017yuyh20050712@hotmail.com

Nan Liu, MD

CONTACT

+8613889903451annan0103@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

CN(2)