NCT03216772

Brief 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)

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

3.6 years

First QC Date

July 8, 2017

Last Update Submit

July 7, 2022

Conditions

Gynecologic Surgery

Keywords

Gynecologic Surgerylarscopymorcellation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device

    End of study - approximately two years

  • Intra- or post-operative complications

    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

  • +2 more secondary outcomes

Study Arms (1)

Olympus PK Morcellator in PneumoLiner

EXPERIMENTAL

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

Device: Olympus PK Morcellator in PneumoLiner

Interventions

Olympus PK Morcellator in PneumoLinerDEVICE

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

Olympus PK Morcellator in PneumoLiner

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Erin Carey, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2017

First Posted

July 13, 2017

Study Start

January 20, 2018

Primary Completion

September 1, 2021

Study Completion

February 1, 2022

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share