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CavatermTM vs TCRE in Women With DUB

Primary Purpose

Dysfunctional Uterine Bleeding

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Thermal Balloon Endometrial Ablation
Transcervical Resection of the Endometrium
Sponsored by
Pnn Medical A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Uterine Bleeding focused on measuring menorrhagia, dysfunctional uterine bleeding, endometrial ablation

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately.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

Sites / Locations

  • Zhu Jiang HospitalRecruiting
  • Guangzhou Southern HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cavaterm

TCRE

Arm Description

Transcervical resection of the endometrium

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2007
Last Updated
May 19, 2008
Sponsor
Pnn Medical A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00549159
Brief Title
CavatermTM vs TCRE in Women With DUB
Official Title
Multicenter Randomized Clinical Trial to Evaluate the Safety and Effectiveness of Cavaterm TM Thermal Balloon Endometrial Ablation in Women With Dysfunctional Uterine Bleeding Compared to Transcervical Resection of the Endometrium (TCRE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Pnn Medical A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of study is to compare the treatment success in the study groups.
Detailed Description
Study success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Uterine Bleeding
Keywords
menorrhagia, dysfunctional uterine bleeding, endometrial ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cavaterm
Arm Type
Experimental
Arm Title
TCRE
Arm Type
Active Comparator
Arm Description
Transcervical resection of the endometrium
Intervention Type
Device
Intervention Name(s)
Thermal Balloon Endometrial Ablation
Intervention Description
Thermal balloon endometrial ablation
Intervention Type
Device
Intervention Name(s)
Transcervical Resection of the Endometrium
Intervention Description
Transcervical resection of the endometrium
Primary Outcome Measure Information:
Title
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
Time Frame
12 months
Secondary Outcome Measure Information:
Title
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanhong Yu, Prof.
Phone
+862061641017
Email
yuyh20050712@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Liu, MD
Phone
+8613889903451
Email
annan0103@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Yu, Prof.
Organizational Affiliation
Guangzhou Southern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhu Jiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi Lei Pan, MD
Facility Name
Guangzhou Southern Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanhong Yu, Prof.

12. IPD Sharing Statement

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CavatermTM vs TCRE in Women With DUB

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