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Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrauterine Morcellation of Uteri Post-Surgery | Experimental | Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heracure Device | Device | Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device or procedure related Adverse Event (AE) | Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline. | Intra-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure | Intra-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gal Meister | Contact | 0549011128 | galmeist1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gal Meister | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36930660 | Derived | Pomeranz M, Schonman R, Yagur Y, Tamir Yaniv R, Klein Z, Daykan Y. An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study. PLoS One. 2023 Mar 17;18(3):e0282149. doi: 10.1371/journal.pone.0282149. eCollection 2023. |
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