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

Heracure Medical

Status: Unknown

Conditions: Vaginal or Laparoscopic Hysterectomy

Treatments: Device: Heracure Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05332132

202019038

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is undergoing hysterectomy due to benign gynecologic disease

Exclusion criteria

• Subject is not suspected of malignancy

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intrauterine Morcellation of Uteri Post-Surgery

Experimental group

Description:

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

Treatment:

Device: Heracure Device