LapBox® Manual Containment System

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The goal is to determine the integrity of the LapBox Manual Containment system in orderto increase surgical safety of morcellation of uterine fibroids during laparoscopichysterectomy and myomectomy.Containment systems are imperative for laparoscopic morcellation due to the potential fortissue dissemination, particularly in cases of undiagnosed malignancy or benign tissuefragments during morcellation of uterine fibroids.Integrity of the LapBox Manual Containment System will be evaluated by indicating thepresence 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 priorto methylene blue being added to determine if there is breakage. The methylene blue dyewill not come in contact with the participant or spill onto the surgical field.The hypothesis is that laparoscopic hysterectomies and myomectomies performed using theLapBox Manual Containment System will result in less leakage when compared to the controlcontainment system.The primary endpoint will be presence or absence of leakage from the LapBox and thecontrol. This will be directly visualized intraoperatively after morcellation takesplace.The secondary endpoint will be the incidence of perforation or rupture incidence in theLapBox or standard of care device and descriptive comments from surgeons for usabilityfeedback.
Epistemonikos ID: 23236148e0fabff9498407ec40c0e5fb49b3b9b3
First added on: Aug 17, 2026