MedDataX Logo

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

NCT02541448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-11-13

No results posted yet for this study

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

Interventions

DEVICE

SurgiQuest AIRSEAL® Insufflation System (AIS)

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.

Sponsors & Collaborators

  • SurgiQuest, Inc.

    collaborator INDUSTRY

  • Cynthia Harris

    lead INDUSTRY

Principal Investigators

  • John P Diaz, MD · South Miami Hospital, Miami Floridaa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-05-18
Completion
2018-07-12

Countries

  • United States

Study Locations

Related Clinical Trials

More Related Trials

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 NCT02541448 on ClinicalTrials.gov