NOT_YET_RECRUITING
Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure
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
🗓️ Study Start (Actual) March 2021
🗓️ Primary Completion (Estimated) November 2025
✅ Study Completion (Estimated) November 2027
👥 Enrollment (Estimated) 102
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Akron, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Pediatric subjects (\<21 years of age)
    • 2. \> 20 kg in weight;
    • 3. Capable and willing to provide parental Informed Consent and patient Assent;
    • 4. Acceptable candidate for laparoscopic surgery;

    Exclusion Criteria:

    • 1. Active cutaneous infection or inflammation;
    • 2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
    • 3. Uncontrolled diabetes mellitus
    • 4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR(international normalized ratio) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
    • 5. Severe co-existing morbidities having a life expectancy of less than 30 days;
    • 6. Currently involved in any other investigational clinical Studies;
    • 7. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
    • 8. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
    • 9. Extreme morbid obesity (BMI greater than 45 kg/m2)
    • 10. Patients presenting with Ascites
Ages Eligible for Study: N/A to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 January 2015
  • First Submitted that Met QC Criteria 18 July 2016
  • First Posted 19 July 2016

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2020
  • Last Update Posted 13 July 2020
  • Last Verified July 2020