LapBox® Manual Containment System

Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07767968
Lead Sponsor: University of Wisconsin, MadisonOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 24Estimated
Last Update Posted: Aug 17, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Jul 2027Estimated
Completion Date: Jul 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
Brief Summary: This study to evaluate the leak integrity of the LapBox Manual Containment System for laparoscopic hysterectomy and myomectomy. The goal is to determine the integrity of this containment system in order to increase surgical safety. 30 adult females who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids will be enrolled and will be on study the day of surgery.
Detailed Description: The goal is to determine the integrity of the LapBox Manual Containment system in order to increase surgical safety of morcellation of uterine fibroids during laparoscopic hysterectomy and myomectomy.

Containment systems are imperative for laparoscopic morcellation due to the potential for tissue dissemination, particularly in cases of undiagnosed malignancy or benign tissue fragments during morcellation of uterine fibroids.

Integrity of the LapBox Manual Containment System will be evaluated by indicating the presence or absence of leakage from testing with methylene blue dye after morcellation. The LapBox and standard of care devices will be moved away from the surgical field prior to methylene blue being added to determine if there is breakage. The methylene blue dye will not come in contact with the participant or spill onto the surgical field.

The hypothesis is that laparoscopic hysterectomies and myomectomies performed using the LapBox Manual Containment System will result in less leakage when compared to the control containment system.

The primary endpoint will be presence or absence of leakage from the LapBox and the control. This will be directly visualized intraoperatively after morcellation takes place.

The secondary endpoint will be the incidence of perforation or rupture incidence in the LapBox or standard of care device and descriptive comments from surgeons for usability feedback.

Conditions

The medical conditions and diseases this study investigates.

Surgery

Interventions

The treatments and procedures being evaluated in this study.

LapBox Manual Containment System
Standard of Care Specimen Bag

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids

Exclusion Criteria:

-

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

Sharon BlohowiakContact

sblohowiak@wisc.edu(608) 262-5977

Locations

Where the study is run and whether each site is currently recruiting.

Meriter

Madison, Wisconsin 53715, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: University of Wisconsin, MadisonOTHER

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