Recruiting

Ultravision™ vs. Airseal®

Sponsor:

Alesi Surgical Ltd.

Code:

NCT04162106

Conditions

Laparoscopic Cholecystectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smoke management during laparoscopic cholecystectomy using the Ultravision™ System

Smoke management during laparoscopic cholecystectomy using the Airseal® iFS

Study Details

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

Study ID

NCT04162106

Start date

Nov, 2019

Status verified date

Nov, 2019

Completion date

Feb, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ultravision™ System

Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System

active comparator: Airseal® iFS

Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS

Interventions

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.

Primary outcome measure

  • Carbon Dioxide Utilization [ Time Frame: Measured from Veress needle insertion to just prior to gall bladder removal ]
  • Quality of Visualization [ Time Frame: Measured from camera insertion through removal ]

Central Contacts and Locations

Central contacts

Jin S Yoo, MD

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

Locations

Duke Regional Hospital

Recruiting

Durham, North Carolina, United States, 27704

More Information

Sponsor

Alesi Surgical Ltd.

Last update posted

Nov 22, 2019

Last verified

Nov, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alesi Surgical Ltd. on 2019-11-22.