NCT03216772

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Olympus Surgical Technologies Europe · Industry
• Sex: Female
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2018-01-20
• Primary completion: 2021-09-01
• Completion: 2022-02-01
• First posted: 2017-07-13
• Last updated: 2022-07-11

Regulatory

• FDA-regulated device study