Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

Olympus

Status: Withdrawn

Conditions: Gynecologic Surgery

Treatments: Device: Olympus PK Morcellator in PneumoLiner

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216772

PK MORCELLATOR-LSH-01

Details and patient eligibility

About

The study is designed to evaluate the safety of performing in-bag morcellation of uterus tissues during laparoscopic hysterectomy (LSH or TLH). Pre- and perimenopausal women, aged 35-50 undergoing laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH)

Sex: Female

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre- and Peri-menopausal woman patient age 35-50 years
• Women with fibroids and indication for laparoscopic hysterectomy at which a morcellators for cutting and extraction of tissue is required.
• Normal Pap test result in the last year
• Hemoglobin level of 10.0 g/dL or more at the time of treatment
• Subject able to comprehend and give informed consent for participation in this study
• Signed informed consent form

Exclusion criteria

• Patient is not considered suitable for a laparoscopic hysterectomy procedure
• Women with:
• Known or suspected gynecologic malignancy
• Known cervical dysplasia
• Postmenopausal women
• Undiagnosed vaginal bleeding
• Abdominal wall thickness is larger than 10 cm
• Atypical hyperplasia or malignancy in preoperative endometrial biopsy.
• Known cognitive disorder
• HIV or any other immunosuppressive disorder
• Liver disease
• Renal failure (Serum creatinine above 2.5 dL/ml)
• Cardiopulmonary disease contraindicating laparoscopic surgery
• History or evidence of gynecologic malignancy within the past five years
• Pace maker, internal defibrillator/cardio converter
• Impaired coagulation parameters
• Previous extensive pelvic surgery
• Psychological/psychiatric disease
• Contraindications to anesthesia or abdominal surgery.
• Concurrent participation in any other clinical study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Olympus PK Morcellator in PneumoLiner

Experimental group

Description:

Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device

Treatment:

Device: Olympus PK Morcellator in PneumoLiner