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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03216772
Other study ID # PK MORCELLATOR-LSH-01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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