Gynecologic Surgery Clinical Trial
Official title:
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
Verified date | July 2022 |
Source | Olympus Surgical Technologies Europe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Olympus Surgical Technologies Europe |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 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. |
End of study - approximately two years | |
Secondary | The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device | Ease of use of the PK MORCELLATOR in conjunction with the PneumoLiner containment device for LSH or TLH. Ease of use will be measured by designated Satisfaction Questionnaire. | End of study - approximately two years | |
Secondary | Intra- or post-operative complications | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) | End of study - approximately two years | |
Secondary | Mean procedure time | Mean procedure time will be measured by hour/minutes. | End of study - approximately two years | |
Secondary | Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | End of study - approximately two years | |
Secondary | Post-operative pain | Post-operative pain will be measured by Visual Analog Score - VAS | End of study - approximately two years | |
Secondary | Hospitalization length | Hospitalization length will be measured by days | End of study - approximately two years | |
Secondary | Specimen weight | Specimen will be measured by weight (gr) | End of study - approximately two years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05071976 -
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
|
N/A | |
Completed |
NCT04549090 -
Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery
|
||
Recruiting |
NCT05526534 -
A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
|
N/A | |
Completed |
NCT03828981 -
A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy
|
N/A | |
Recruiting |
NCT05910385 -
TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)
|
N/A | |
Recruiting |
NCT04392674 -
Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
|
N/A | |
Not yet recruiting |
NCT04423172 -
Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
|
N/A | |
Not yet recruiting |
NCT05296928 -
Postoperative Pain Score of Laparoscopic Gynecological Surgeries
|
N/A | |
Not yet recruiting |
NCT04947982 -
Low Versus Standard Pressure Pneumoperitoneum
|
N/A | |
Recruiting |
NCT03795766 -
Nausea and Vomiting After Gynecologic Surgery
|
||
Recruiting |
NCT03085732 -
The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies
|
N/A | |
Completed |
NCT04063085 -
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
|
N/A | |
Completed |
NCT03517228 -
Pilot Trial of the Robotic Uterine Manipulator
|
N/A | |
Not yet recruiting |
NCT05308810 -
Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery
|
||
Withdrawn |
NCT02351440 -
Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery
|
Phase 4 |