LapBox® Manual Containment System

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07767968
Status
Not Yet Recruiting

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Conditions

  • Surgery

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LapBox Manual Containment System — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LapBox Manual Containment System
    N=12
  • Active Comparator: Standard Specimen Bag
    N=12

Primary Outcome Measure

Presence or Absence of Leakage [ Time Frame: data collected intraoperatively (on day of surgery, only study visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MeriterMadisonWisconsin53715-

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By research site
Meriter· Madison, WI

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