LapBox® Manual Containment System

NCT07767968 | Not Yet Recruiting FDA Device

• 4 other identifiers: 2026-0071Protocol Version 6/22/26SMPH | OBGYN Administration238739
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery

Keywords

laparoscopic hysterectomy; laparoscopic myomectomy; uterine fibroids; morcellation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Incidence of Perforation or Rupture

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

Study Arms (2)

LapBox Manual Containment System

EXPERIMENTAL

N=12

Device: LapBox Manual Containment System

Standard Specimen Bag

ACTIVE COMPARATOR

N=12

Device: Standard of Care Specimen Bag

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.

Also known as: LapBox Manual

LapBox Manual Containment System

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.

Also known as: endoscopic specimen retrieval bag

Standard Specimen Bag

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Meriter

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Bala Bhagavath, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Blohowiak

CONTACT

(608) 262-5977; sblohowiak@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6 participants will be enrolled first for practice with the LapBox device, per protocol, no data will be collected from these participants. This is followed by a randomized investigative trial on 24 patients. Block randomization will occur at the time of surgery after morcellation of uterine fibroids. Patients will be randomized in to 2 groups using different containment systems (1:1 comparing LapBox System vs. standard specimen bag).

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)