Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

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