Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

Study Overview
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Brief Summary
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Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.

Detailed Description
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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.

Official Title
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Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

Conditions
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Laparoscopic Abdominal Surgery

Intervention / Treatment
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* Device: EndoClear Lens Cleaning Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EndoClear used<br>The EndoClear device is used during a laparoscopic abdominal surgery. | Device: EndoClear Lens Cleaning Device<br>* EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.<br>* Other names: Virtual Ports, Ltd;|
| No Intervention: Control<br>EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic, EndoClear, Lens Cleaning Device