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

Not Applicable

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System; Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS

• Registration Number: NCT04162106
• Lead Sponsor: Alesi Surgical Ltd.

Brief 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.

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22
• Primary Completion: 2020-01
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultravision™ System	Smoke management during laparoscopic cholecystectomy using the Ultravision™ System	Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System
Airseal® iFS	Smoke management during laparoscopic cholecystectomy using the Airseal® iFS	Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke Regional Hospital; 🇺🇸 Durham, North Carolina, United States