Clinical trial: Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy (NCT03216772)

Eligibility criteria:
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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction