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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162106
• Other study ID #: Pro00103233
• Status: Recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: February 2020

Study information

• Verified date: November 2019
• Source: Alesi Surgical Ltd.
• Contact: Jin S Yoo, MD
• Phone: 919-470-7038
• Email: sean.greene[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke Regional Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Alesi Surgical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Quality of Visualization	The quality of visualization in the laparoscopic field	Measured from camera insertion through removal
Secondary	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
Secondary	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
Secondary	Procedure Time	Overall procedure time in minutes	Measured from the insertion of the camera to the time of closure
Secondary	End tidal CO2 Volume	End tidal volume of CO2	Measured at Veress needle insertion and just prior to gall bladder removal
Secondary	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
Secondary	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
Secondary	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
Secondary	Case Complexity	Case complexity compared to surgeon experience. Recorded as simple or routine or complex/difficult.	Immediately post-procedure
Secondary	Pain Assessment	Pre and Post operative pain surveys	Pre-procedure and 1 to 7 days post procedure
Secondary	Pain Medications	Amount and type of pain medication administered and record of use following the procedure	1 to 7 days post procedure