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

Status unconfirmed · Not applicable

Conditions studied: Laparoscopic Cholecystectomy

In brief

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.

Key facts

Study ID

NCT04162106

Run by

Alesi Surgical Ltd.

People needed

60

Starts

2019-11-01

Expected to finish

2020-02-01

Last updated by the study team

2019-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Duke Regional Hospital — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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