Dysfunctional Uterine BleedingPhase 4NCT00549159
CavatermTM vs TCRE in Women With DUB
A Phase 4 study testing Thermal Balloon Endometrial Ablation and Transcervical Resection of the Endometrium in people with Dysfunctional Uterine Bleeding, run by Pnn Medical A/S at 2 sites in China.
Trial summary
The purpose of study is to compare the treatment success in the study groups. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- Thermal Balloon Endometrial Ablation and Transcervical Resection of the Endometrium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhu Jiang Hospital
Guangzhou, Guangdong, 510282
Shi Lei Pan, MD
- Recruiting
Guangzhou Southern Hospital
Guangzhou, Guangdong, 510515
Yanhong Yu, Prof.
About this study
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)
The purpose of study is to compare the treatment success in the study groups.
Read the 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.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- Thermal Balloon Endometrial Ablation, Transcervical Resection of the Endometrium
- Keywords
- menorrhagia, dysfunctional uterine bleeding, endometrial ablation
- Medical subject headings
- Metrorrhagia, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Balloon Endometrial AblationDevice
Thermal balloon endometrial ablation
Transcervical Resection of the EndometriumDevice
Transcervical resection of the endometrium
| Study group | Role | What they receive |
|---|---|---|
| Cavaterm | Experimental | Not described Receives: Device: Thermal Balloon Endometrial Ablation |
| TCRE | Active comparator | Transcervical resection of the endometrium Receives: Device: Transcervical Resection of the Endometrium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
Measured: 12 months
Secondary outcomes (1)
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pnn Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yanhong Yu, Prof., Principal investigator, Guangzhou Southern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549159
- Sponsor's protocol ID
- 2006-0026-06 dd20070920
- Status last verified
- May 2008
- First submitted
- 24 Oct 2007
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00549159
- Acronym / sponsor ID
- 2006-0026-06 dd20070920
- Conditions
- Dysfunctional Uterine Bleeding
- Keywords
- menorrhagia, dysfunctional uterine bleeding, endometrial ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Pnn Medical A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavaterm | Experimental | Device: Thermal Balloon Endometrial Ablation |
| TCRE | Active comparator | Device: Transcervical Resection of the EndometriumTranscervical resection of the endometrium |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal Balloon Endometrial AblationThermal balloon endometrial ablation | Device | Cavaterm |
| Transcervical Resection of the EndometriumTranscervical resection of the endometrium | Device | TCRE |
Primary outcome
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
Time frame: 12 months
1 secondary outcome
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanhong Yu, Prof. principal investigator
Guangzhou Southern Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thermal Balloon Endometrial Ablation and Transcervical Resection of the Endometrium in people with Dysfunctional Uterine Bleeding, run by Pnn Medical A/S at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Yu, Prof. (+862061641017, yuyh20050712@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.