- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197222
Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Legacy Good Samaritan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >18 years of age
- Patients undergoing laparoscopic abdominal surgery
Exclusion Criteria:
- Patients with known coagulopathy or bleeding tendencies
- Intra-abdominal abscesses
- Pregnancy
- Non-elective laparoscopic surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EndoClear used
The EndoClear device is used during a laparoscopic abdominal surgery.
|
EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.
Other Names:
|
No Intervention: Control
EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lee L Swanstrom, MD, The Oregon Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 940
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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