TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery

N/A

Waitlist Available

Led By James Lau, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 minutes

Summary

This trial is testing a new tool called TPAD that helps surgeons safely insert a needle and tube into the abdomen during keyhole surgery. It aims to make the procedure safer and easier for patients undergoing this type of surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgeon satisfaction survey

Secondary study objectives

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TauTona Pneumoperitoneum Assist Device (TPAD)Experimental Treatment1 Intervention

Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed.

Group II: Standard of Care (SOC)Placebo Group1 Intervention

Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veresss needle was in the correct location (e.g. drop test), insufflation was initiated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TauTona Pneumoperitoneum Assist Device (TPAD)

2022

N/A

~30

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