Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

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

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)

Study Overview

• Status: Withdrawn
• Conditions: Gynecologic Surgery
• Intervention / Treatment: Device: Olympus PK Morcellator in PneumoLiner

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olympus PK Morcellator in PneumoLiner; Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device	Device: Olympus PK Morcellator in PneumoLiner; Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intra- or post-operative complications	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)	End of study - approximately two years
Mean procedure time	Mean procedure time will be measured by hour/minutes.	End of study - approximately two years
Estimated blood loss during operation	Blood loss during operation will be measured by volume (mL)	End of study - approximately two years
Post-operative pain	Post-operative pain will be measured by Visual Analog Score - VAS	End of study - approximately two years
Hospitalization length	Hospitalization length will be measured by days	End of study - approximately two years
Specimen weight	Specimen will be measured by weight (gr)	End of study - approximately two years

Collaborators and Investigators

• Sponsor: Olympus Surgical Technologies Europe
• Investigators: Principal Investigator: Erin Carey, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: July 8, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Gynecologic Surgery; larscopy; morcellation
• Other Study ID Numbers: PK MORCELLATOR-LSH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes