Trials / Unknown
UnknownNCT00549159
CavatermTM vs TCRE in Women With DUB
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)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- Sponsor
- Pnn Medical A/S · Industry
- Sex
- Female
- Age
- 30 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Thermal Balloon Endometrial Ablation | Thermal balloon endometrial ablation |
| DEVICE | Transcervical Resection of the Endometrium | Transcervical resection of the endometrium |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2007-10-25
- Last updated
- 2008-05-22
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT00549159. Inclusion in this directory is not an endorsement.