LapBox® Manual Containment System

ConditionSurgery

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: LapBox Manual Containment SystemExperimental treatment 1 intervention

Group B: Standard Specimen BagActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Secondary outcomes

Incidence of Perforation or Rupture

Time frame

data collected intraoperatively (on day of surgery, only study visit)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: