SurgeryNCT07767968
LapBox® Manual Containment System
A study testing LapBox Manual Containment System in people with Surgery, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Surgery
- What is being tested?
- LapBox Manual Containment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
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.
Read the detailed description
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.
- Conditions
- Surgery
- Being tested
- LapBox Manual Containment System, Standard of Care Specimen Bag
- Keywords
- laparoscopic hysterectomy, laparoscopic myomectomy, uterine fibroids, morcellation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapBox Manual Containment SystemDevice
Also called LapBox Manual
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 BagDevice
Also called endoscopic specimen retrieval bag
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 group | Role | What they receive |
|---|---|---|
| LapBox Manual Containment System | Experimental | N=12 Receives: Device: LapBox Manual Containment System |
| Standard Specimen Bag | Active comparator | N=12 Receives: Device: Standard of Care Specimen Bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: data collected intraoperatively (on day of surgery, only study visit)
Secondary outcomes (1)
Incidence of Perforation or Rupture
Measured: data collected intraoperatively (on day of surgery, only study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bala Bhagavath, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767968
- Sponsor's protocol ID
- 2026-0071
- Other IDs
- Protocol Version 6/22/26, SMPH | OBGYN Administration, 238739
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07767968
- Acronym / sponsor ID
- 2026-0071
- Conditions
- Surgery
- Keywords
- laparoscopic hysterectomy, laparoscopic myomectomy, uterine fibroids, morcellation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| LapBox Manual Containment System | Experimental | Device: LapBox Manual Containment SystemN=12 |
| Standard Specimen Bag | Active comparator | Device: Standard of Care Specimen BagN=12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LapBox Manual Containment SystemAlso: LapBox ManualThe 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. | Device | LapBox Manual Containment System |
| Standard of Care Specimen BagAlso: endoscopic specimen retrieval bagMeriter 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. | Device | Standard Specimen Bag |
Primary outcome
Presence or Absence of Leakage
Time frame: data collected intraoperatively (on day of surgery, only study visit)
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.
1 secondary outcome
Incidence of Perforation or Rupture
Time frame: data collected intraoperatively (on day of surgery, only study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bala Bhagavath, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LapBox Manual Containment System in people with Surgery, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Blohowiak ((608) 262-5977, sblohowiak@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of Leakage (time frame: data collected intraoperatively (on day of surgery, only study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.