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

NCT02837601 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-07-13

No results posted yet for this study

Summary

A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:

1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.

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.

Sponsors & Collaborators

  • Akron Children's Hospital

    lead OTHER

Principal Investigators

  • Todd Ponsky, MD · Akron Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2025-11-30
Completion
2027-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02837601 on ClinicalTrials.gov