Clinical Trial

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

Study acronym: PRESSURE
Not Yet Recruiting
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Record status
This record was last updated July 13, 2020 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2016-07-18; most recent amendment 2020-07-10.
Trial Details
NCT Number NCT02837601
Lead Sponsor Akron Children's Hospital
Conditions Shoulder Pain
Enrollment 102 participants
Start Date 2021-03
Primary Completion 2025-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2020-07-13