An interventional study of LapBox Manual Containment System and Standard of Care Specimen Bag in Surgery, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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Exclusion Criteria:
-
N=12
Device: LapBox Manual Containment System
N=12
Device: Standard of Care Specimen Bag
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.
Also known as: LapBox Manual
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.
Also known as: endoscopic specimen retrieval bag
Presence or Absence of Leakage
Integrity will be evaluated by indicating the presence or absence of leakage after morcellation and subsequent testing with methylene blue dye during laparoscopic hysterectomy or myomectomy.
Time frame: data collected intraoperatively (on day of surgery, only study visit)
Incidence of Perforation or Rupture
Time frame: data collected intraoperatively (on day of surgery, only study visit)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.
Of 52 non-industry interventional studies with no phase under Leiomyoma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 9 months is below that.
Counting every sponsor, half of 57 studies reached it within 31 months; a quarter within 15 and three quarters within 43.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 1, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison →