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

NCT ID: NCT05332132

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2022-12-31

Brief Summary

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Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.

Detailed Description

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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.

Conditions

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Vaginal or Laparoscopic Hysterectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Intrauterine Morcellation of Uteri Post-Surgery

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

Group Type EXPERIMENTAL

Heracure Device

Intervention Type DEVICE

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

Interventions

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Heracure Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is undergoing hysterectomy due to benign gynecologic disease

Exclusion Criteria

* Subject is not suspected of malignancy
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heracure Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gal Meister

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gal Meister

Role: CONTACT

0549011128

Facility Contacts

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Aisa Kaizler

Role: primary

097471041

References

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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.

Reference Type DERIVED
PMID: 36930660 (View on PubMed)

Other Identifiers

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202019038

Identifier Type: -

Identifier Source: org_study_id

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