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

NCT04162106 | Unknown FDA Device

• 1 other identifier: Pro00103233
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

• Diathermy Power Setting

  Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy

• Procedure Time

  Measured from the insertion of the camera to the time of closure

• End tidal CO2 Volume

  Measured at Veress needle insertion and just prior to gall bladder removal

• Laparoscope cleaning

  Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy

Study Arms (2)

Ultravision™ System

ACTIVE COMPARATOR

Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System

Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System

Airseal® iFS

ACTIVE COMPARATOR

Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS

Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS

Interventions

Smoke management during laparoscopic cholecystectomy using the Ultravision™ System DEVICE

The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.

Ultravision™ System

Smoke management during laparoscopic cholecystectomy using the Airseal® iFS DEVICE

The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.

Airseal® iFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alesi Surgical Ltd.: lead

Study Sites (1)

Duke Regional Hospital

Durham, North Carolina, 27704, United States

RECRUITING

Central Study Contacts

Jin S Yoo, MD

CONTACT

919-470-7038; sean.greene@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)