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| Name | Class |
|---|---|
| Erbe Elektromedizin GmbH | INDUSTRY |
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The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified thermofu-sion and dissection instrument BiCision® in comparison with the long established Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy (LASH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiCision Arm | Experimental | Coagulation with BiCision |
|
| Ultracision Arm | Active Comparator | Coagulation with Ultracision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiCision® | Device |
| ||
| Ultracision® Har-monic Scalpel(Ethicon) |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | The primary objective is the operation time for each preparation side and instrument needed from the beginning of the removal of the cornual structure of the uterus (uterine cornu) till the completely removal of the parametric tissue directly before removal of the corpus uteri from the cervix. | Participants will be followed for the duration of hospital stay, an expexted average of 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diethelm Wallwiener, Professor | University Hospital Tuebingen | Study Chair |
| Bernhard Krämer, MD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Tübingen | 72076 | Germany |
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