Ex Vivo Study of the Heracure Device for Intra-uterine Morcellation After Vaginal or Laparoscopic Hysterectomy

Heracure Medical Ltd.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Vaginal or Laparoscopic Hysterectomy

Interventions

Heracure DeviceDEVICE

Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is undergoing hysterectomy due to benign gynecologic disease Exclusion Criteria: * Subject is not suspected of malignancy

Locations (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Intra-operation

Secondary Outcomes

Device Success

Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure

Time frame: Intra-operation

Central Contacts

Gal Meister

CONTACT

0549011128 galmeist1@gmail.com

Data from ClinicalTrials.gov

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