At a glance
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The Feasibility of Using the Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for the Treatment of Endometriosis
In Brief
A clinical study evaluating Ultravision™ Visual Field Clearing System and Ultravision Ionwand™ for Endometriosis. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This is a prospective single arm study. The study will enroll 20 patients. Comparisons to prior clinical trials and published literature will be made to assess the relative significance of the study results.The study will enroll patients indicated for laparoscopic surgery to treat endometriosis. Patients must meet all inclusion/exclusion criteria. There are five main study objectives: 1. Demonstrate the feasibility of undertaking low impact laparoscopic surgery for endometriosis when using the Ultravision™ System. 2. Assess the impact of Ultravision on visual field clarity. 3. Determine the ability to complete the procedure while maintaining an abdominal pressure of \< 10mmHg. 4. Quantify the consumption of CO2. 5. Collect data on additional clinical outcomes associated with the use of Ultravision and low impact surgery (i.e. end tidal CO2 levels (EtCO2), adverse events, cosmesis outcome, postoperative pain levels and pain medications).
Study Details
Timeline
Interventions
Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation
The Ionwand™ is introduced into the abdomen through either the Ultravision™ 5mm Trocar or a 2.5 mm percutaneous catheter. The Ionwand™ provides the source of electrons that create the negative ions that transiently charge the surgical smoke particles and accelerate their sedimentation.