Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation.

The hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of In-bag Morcellation

NCT03281460

Uterine Myomatosis Laparoscopy Hysterectomy, Vaginal

COMPLETED NA

Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

NCT03216772

Gynecologic Surgery

WITHDRAWN NA

Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

NCT03570879

Myoma;Uterus

UNKNOWN

The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study

NCT05811286

Endometrial Polyp Benign Retained Products of Conception Myoma;Uterus

COMPLETED NA

Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

NCT04392674

Gynecologic Surgery

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.

In order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. Due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag.

This study will be evaluating the efficacy of contained morcellation using a specific specimen bag. Morcellation will be performed in the designated bag. The bag will then be removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leiomyoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EcoSac 46 400 ECO-T morcellation bag cohort

Prospective study of one cohort of subjects undergoing power morcellation within the EcoSac 46 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.

Group Type OTHER

EcoSac 400 ECO-T

Intervention Type DEVICE

Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag. This study is a pilot study with one arm (all patients will use the new EcoSac400 ECO-T bag.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EcoSac 400 ECO-T

Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag. This study is a pilot study with one arm (all patients will use the new EcoSac400 ECO-T bag.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult premenopausal women (equal or greater than 18 years old)
* no symptoms of menopause
* undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids
* not candidates for specimen removal via mini-laparotomy incision (as deemed by the study surgeon) or who have refused mini-laparotomy
* endometrial biopsy with no suspicion for malignancy

Exclusion Criteria

* known or suspected malignancy
* peri- or post-menopausal women
* specimen that can be removed without power morcellation (e.g., vaginally or through laparoscopic trocars)
* adults unable to consent.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No