Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure

NANot yet recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

March 31, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2027

Conditions
Shoulder Pain
Interventions
DEVICE

AirSeal® Insufflation System (AIS)

The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier.

Trial Locations (1)

44308

Children's Hospital Medical Center of Akron, Akron

All Listed Sponsors
lead

Akron Children's Hospital

OTHER

NCT02837601 - Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure | Biotech Hunter | Biotech Hunter