Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
|Laparoscopic Abdominal Surgery||Device: EndoClear Lens Cleaning Device||Early Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
|Official Title:||Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device|
|Study Start Date:||March 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: EndoClear used
The EndoClear device is used during a laparoscopic abdominal surgery.
Device: EndoClear Lens Cleaning Device
EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.
Other Name: Virtual Ports, Ltd
No Intervention: Control
EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.
The ability to perform laparoscopic surgery safely and effectively depends on the uninterrupted progression of the operation. Any interruptions to the normal workflow of the procedure threatens to cause distraction which in the least can lengthen the operative time leading to increased hospital operating costs and exposing the patient to unnecessary excess anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or technique resulting in injury to the patient.
Interruptions in the operating room can take many forms, from conversations to equipment malfunction. The goal of this study is to focus on one particular type of interruption unique to laparoscopic surgery - lens cleaning. It is quite common during the course of the procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from cautery devices. This necessitates having to remove the camera from the patient, cleaning it outside of the body, applying de-fog solution, reinserting it into the body, and having to reacquire the original camera position and image. This can be quite dangerous particularly in the middle of operative step, such as when there is ongoing bleeding, or when there are sharp or hot instruments within the body. Pilot data from own group demonstrates that the camera may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an operation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197222
|United States, Oregon|
|Legacy Good Samaritan|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Lee L Swanstrom, MD||The Oregon Clinic|