NCT04162106

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alesi Surgical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
DEVICE	Smoke management during laparoscopic cholecystectomy using the Ultravision™ System	The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.
DEVICE	Smoke management during laparoscopic cholecystectomy using the Airseal® iFS	The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-01-01
• Completion: 2020-02-01
• First posted: 2019-11-14
• Last updated: 2019-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study