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

Alesi Surgical

Status: Unknown

Conditions: Laparoscopic Cholecystectomy

Treatments: Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System; Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04162106

Pro00103233

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ultravision™ System

Active Comparator group

Description:

Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System

Treatment:

Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System

Airseal® iFS

Active Comparator group

Description:

Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS

Treatment:

Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS