Clinical trial NCT04162106: Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Alesi Surgical Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Carbon Dioxide Utilization
timeFrame: Measured from Veress needle insertion to just prior to gall bladder removal
measure: Quality of Visualization
timeFrame: Measured from camera insertion through removal
Secondary outcomes:
measure: Procedure time for Diathermy use
timeFrame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
measure: Diathermy Power Setting
timeFrame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
measure: Procedure Time
timeFrame: Measured from the insertion of the camera to the time of closure
measure: End tidal CO2 Volume
timeFrame: Measured at Veress needle insertion and just prior to gall bladder removal
measure: Laparoscope cleaning
timeFrame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
measure: Pneumoperitoneum Pressure
timeFrame: Starting pneumoperitoneum pressure at the time of camera trocar insertion, record the maximum pressure that occurred during the procedure
measure: Trocar Venting
timeFrame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
measure: Case Complexity
timeFrame: Immediately post-procedure
measure: Pain Assessment
timeFrame: Pre-procedure and 1 to 7 days post procedure
measure: Pain Medications
timeFrame: 1 to 7 days post procedure
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Regional Hospital
state: North Carolina
Study officials:
References: