Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS

Study Overview
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Brief Summary
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This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.

Detailed Description
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The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of lower pneumoperitoneal pressures whilst maintaining an adequate visual field throughout the procedure with low demand for CO2 replenishment to maintain pneumoperitoneal pressure. Comparisons in terms of surgical field visualization, procedure times, and CO2 consumption will be conducted in order to determine whether or not any clinical benefits are derived from the use of the Ultravision™ System compared to the Airseal® iFS. Low pressure laparoscopy for this study is set at 10mmHg. This is a prospective, open-label, randomized controlled study. The study will include two study arms. Patients undergoing laparoscopic cholecystectomy will be randomized to either Ultravision (study arm 1) or Airseal® iFS (study arm 2). Both groups will conduct the procedure at 10mmHg, considered to be low pressure/low impact laparoscopic surgery. The study will enroll 30 patients, 15 per group. Both devices are being used according to their cleared label claims.

Official Title
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Open Label, Single Center, Randomized Study Evaluating the Feasibility of the Ultravision™ Visual Field Clearing System in Low Pressure Laparoscopic Cholecystectomy Compared To AirsealL® IFS

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System
* Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 18 years or older Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure Agrees to attend all follow-up assessments Is indicated for elective laparoscopic cholecystectomy Exclusion Criteria: Existing comorbidities that would contraindicate them for laparoscopic surgery Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively Body Mass Index > 50 Be pregnant (if female) Has a condition of unrelated chronic pain requiring medication

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultravision™ System<br>Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System | Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System<br>* The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.<br>|
| Active Comparator: Airseal® iFS<br>Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS | Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS<br>* The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon Dioxide Utilization | The volume measured in Liters of Carbon Dioxide consumed during the procedure | Measured from Veress needle insertion to just prior to gall bladder removal | 
| Quality of Visualization | The quality of visualization in the laparoscopic field | Measured from camera insertion through removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time for Diathermy use | Measures the procedure time in minutes where diathermy is used | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | 
| Diathermy Power Setting | Highest diathermy setting used during the procedure | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | 
| Procedure Time | Overall procedure time in minutes | Measured from the insertion of the camera to the time of closure | 
| End tidal CO2 Volume | End tidal volume of CO2 | Measured at Veress needle insertion and just prior to gall bladder removal | 
| Laparoscope cleaning | The number of times during the procedure that the laparoscope must be removed for cleaning to maintain visual field | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | 
| Pneumoperitoneum Pressure | The pneumoperitoneum pressure during the procedure and record of any increase beyond 10mmHg for visualization | Starting pneumoperitoneum pressure at the time of camera trocar insertion, record the maximum pressure that occurred during the procedure | 
| Trocar Venting | The number of times the trocar is used to vent during the procedure for visualization | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | 
| Case Complexity | Case complexity compared to surgeon experience. Recorded as simple or routine or complex/difficult. | Immediately post-procedure | 
| Pain Assessment | Pre and Post operative pain surveys | Pre-procedure and 1 to 7 days post procedure | 
| Pain Medications | Amount and type of pain medication administered and record of use following the procedure | 1 to 7 days post procedure |