Clinical trial · Interventional
LapBox® Manual Containment System
Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LapBox Manual Containment System | Device | — | UNRESOLVED |
| Standard of Care Specimen Bag | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LapBox Manual Containment System
- description
- N=12
- interventionNames
- Device: LapBox Manual Containment System
- type
- ACTIVE_COMPARATOR
- label
- Standard Specimen Bag
- description
- N=12
- interventionNames
- Device: Standard of Care Specimen Bag
Primary outcomes (1)
- measure
- Presence or Absence of Leakage
- timeFrame
- data collected intraoperatively (on day of surgery, only study visit)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids Exclusion Criteria: \-
References
Publications (0)
Data not yet available