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

Not Applicable

• Conditions: Vaginal or Laparoscopic Hysterectomy
• Interventions: Device: Heracure Device

• Registration Number: NCT05332132
• Lead Sponsor: Heracure Medical Ltd.

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.

Study Timeline

• Study First Submitted: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-12
• Study Start: 2022-04-18
• Study First Posted: 2022-04-18
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-25
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Subject is undergoing hysterectomy due to benign gynecologic disease

Exclusion Criteria

• Subject is not suspected of malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrauterine Morcellation of Uteri Post-Surgery	Heracure Device	Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Device Success	Intra-operation	Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel