Vaginal or Laparoscopic Hysterectomy
Conditions
Brief summary
Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
Detailed description
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.
Interventions
DEVICEHeracure Device
Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)
Sponsors
Heracure Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is undergoing hysterectomy due to benign gynecologic disease
Exclusion criteria
* Subject is not suspected of malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device or procedure related Adverse Event (AE) | Intra-operation | Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Intra-operation | Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure |
Countries
Israel
Contacts
Primary ContactGal Meister
Outcome results
None listed