Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03216772
• Other study ID #: PK MORCELLATOR-LSH-01
• Status: Withdrawn
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: February 2022

Study information

• Verified date: July 2022
• Source: Olympus Surgical Technologies Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Gynecologic Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Surgical Technologies Europe

Outcome

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