LapBox Containment System for Surgery in Uterine Fibroids

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

BB

Bala Bhagavath, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for adult women who need laparoscopic surgery (hysterectomy or myomectomy) to treat uterine fibroids. Participants will be enrolled on the day of their surgery.

Inclusion Criteria

I need a laparoscopic hysterectomy or myomectomy for my uterine fibroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Evaluation of the LapBox Manual Containment System during laparoscopic hysterectomy or myomectomy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LapBox Manual Containment System

Trial Overview

The study compares a new device called the LapBox Manual Containment System with the standard specimen bag used during minimally invasive surgeries, aiming to see which better prevents leaks when removing tissue.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: LapBox Manual Containment SystemExperimental Treatment1 Intervention
Group II: Standard Specimen BagActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+