Clinical Research Directory
Browse clinical research sites, groups, and studies.
LapBox® Manual Containment System
Sponsor: University of Wisconsin, Madison
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.
Official title: Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-10
Completion Date
2027-07
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
LapBox Manual Containment System
The LapBox Manual introduces a double wall, pressure resistant system to maintain safe separation between the cutting instrument and chamber wall. The LapBox Manual is already FDA-approved for use so this will be a post-market analysis.
Standard of Care Specimen Bag
Meriter has an endoscopic specimen retrieval bag which will be the standard of care specimen bag depending on the size of the uterine fibroids. The bag can be deployed through a 15 mm port. The standard bag is selected depending on the size of the uterine fibroids.
Locations (1)
Meriter
Madison, Wisconsin, United States