Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
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.
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 morcellat…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids Exclusion Criteria: \-
Interventions
- DeviceLapBox 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.
- DeviceStandard 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.
Location
- MeriterMadison, Wisconsin