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Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

NCT03216772 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-11

No results posted yet for this study

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)

Conditions

  • Gynecologic Surgery

Interventions

DEVICE

Olympus PK Morcellator in PneumoLiner

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

Sponsors & Collaborators

  • Olympus Surgical Technologies Europe

    lead INDUSTRY

Principal Investigators

  • Erin Carey, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-20
Primary Completion
2021-09-30
Completion
2022-02-28
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216772 on ClinicalTrials.gov