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

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System; Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Recruiting
      • Duke Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultravision™ System; Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System	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.
Active Comparator: Airseal® iFS; Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of Visualization	The quality of visualization in the laparoscopic field	Measured from camera insertion through removal

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alesi Surgical Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00103233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No