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Device

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 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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,091 Total Patients Enrolled
TauTona GroupIndustry Sponsor
3 Previous Clinical Trials
102 Total Patients Enrolled
James LauLead Sponsor
~9 spots leftby Dec 2025