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

May 23, 2022 updated by: Heracure Medical Ltd.

Evaluation of the Heracure Device for Hysterectomy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject is undergoing hysterectomy due to benign gynecologic disease

Exclusion Criteria:

  • Subject is not suspected of malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrauterine Morcellation of Uteri Post-Surgery
Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)
Device: Heracure Device
Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device or procedure related Adverse Event (AE)
Time Frame: Intra-operation
Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline.
Intra-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: Intra-operation
Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure
Intra-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heracure Medical Ltd.

Investigators

  • Study Director: Gal Meister, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 202019038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaginal or Laparoscopic Hysterectomy

Clinical Trials on Heracure Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe