Safety and Efficacy of Using PK Morcellator With Pneumoliner Bag for Laparoscopic Morcellation With Laparoscopic Instrument for Tissue Containment and Removal During Laparoscopic Supracervical Hysterectomy or Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The safety of using the PK MORCELLATOR in conjunction with the PneumoLiner containment device for contained cutting and extracting tissue during laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH).
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The safety of using the PK MORCELLATOR in conjunction with the PneumoLiner containment device for contained cutting and extracting tissue during laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH).
时间窗: End of study - approximately two years
The safety of using the PK MORCELLATOR within the PneumoLiner containment bag for cutting and extracting tissue during LSH or TLH procedure will be determined by the probability of failure during in-bag morcellation procedure. * Failure is defined as "disruption of the isolation bag (using dye leak testing) or visible tissue dissemination". * Patient is defined "success" if no failure was detected as a result of the procedure. * Study safety success will be declared if no more than 1 failure (bag rapture) will be observed in 140 procedures.
次要结局
- Intra- or post-operative complications(End of study - approximately two years)
- Hospitalization length(End of study - approximately two years)
- Mean procedure time(End of study - approximately two years)
- Estimated blood loss during operation(End of study - approximately two years)
- Post-operative pain(End of study - approximately two years)
- Specimen weight(End of study - approximately two years)
- The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device(End of study - approximately two years)