Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Quality of Visualization [Measured from camera insertion through removal]
The quality of visualization in the laparoscopic field
Secondary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- Case Complexity [Immediately post-procedure]
Case complexity compared to surgeon experience. Recorded as simple or routine or complex/difficult.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is 18 years or older
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Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
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Agrees to attend all follow-up assessments
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Is indicated for elective laparoscopic cholecystectomy
Exclusion Criteria:
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Existing comorbidities that would contraindicate them for laparoscopic surgery
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Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
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Body Mass Index > 50
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Be pregnant (if female)
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Has a condition of unrelated chronic pain requiring medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Regional Hospital | Durham | North Carolina | United States | 27704 |
Sponsors and Collaborators
- Alesi Surgical Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00103233