Pneumoperitoneum Management With SurgiQuest AirSeal at Low vs. Higher Pressure ( PRESSURE )

NCT02541448 | Completed

• 1 other identifier: PRT DD030316
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate physician preference related to the use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of pneumoperitoneum.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of shoulder pain

  Incidence of reported shoulder pain

  participants will be followed for the duration of hospital stay, an expected average of 24 hours

Study Arms (2)

AIS at 9±1mmHg

ACTIVE COMPARATOR

Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg

Device: SurgiQuest AIRSEAL® Insufflation System (AIS)

AIS at 15±1mmHg

ACTIVE COMPARATOR

Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 15±1mmHg.

Device: SurgiQuest AIRSEAL® Insufflation System (AIS)

Interventions

SurgiQuest AIRSEAL® Insufflation System (AIS) DEVICE

The SurgiQuest AirSeal Optical Trocar \& Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas (establish and maintain pneumoperitoneum), to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

Also known as: AIS

AIS at 15±1mmHg; AIS at 9±1mmHg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age;
• Capable and willing to give informed consent;
• Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery;

You may not qualify if:

• Advanced refusal of blood transfusion, if necessary;
• Active systemic or cutaneous infection or inflammation;
• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
• Uncontrolled diabetes mellitus
• Known, significant history of bleeding diathesis, coagulopathy, Von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
• Severe co-existing morbidities having a life expectancy of less than 30 days;
• Currently involved in any other investigational clinical Studies;
• Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• Renal insufficiency (serum creatinine of \> 2.5 mg/dl);
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
• Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
• Patients presenting with Ascites -

Sponsors & Collaborators

• Cynthia Harris: lead
• SurgiQuest, Inc.: collaborator

Study Sites (1)

South Miami Hospital

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John P Diaz, MD

  South Miami Hospital, Miami Floridaa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Studies

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 4, 2015
• Study Start: July 1, 2015
• Primary Completion: May 18, 2016
• Study Completion: July 12, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

US (1)