LapBox® Manual Containment System
Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Sharon Blohowiak
- Telefonnummer: (608) 262-5977
- E-mail: sblohowiak@wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53715
- Meriter
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LapBox Manual Containment System
N=12
|
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.
Andre navne:
|
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Aktiv komparator: Standard Specimen Bag
N=12
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence or Absence of Leakage
Tidsramme: 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.
|
data collected intraoperatively (on day of surgery, only study visit)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of Perforation or Rupture
Tidsramme: data collected intraoperatively (on day of surgery, only study visit)
|
data collected intraoperatively (on day of surgery, only study visit)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Bala Bhagavath, MD, UW School of Medicine and Public Health
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-0071
- Protocol Version 6/22/26 (Anden identifikator: UW Madison)
- SMPH | OBGYN Administration (Anden identifikator: UW Madison)
- 238739 (Anden identifikator: OnCore ID)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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