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N/A N=31 Randomized Treatment

Device to Assist With Abdominal Access During Laparoscopic Surgery

Laparoscopic Surgery

Bottom Line

View on ClinicalTrials.gov: NCT04392635 ↗
Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Jul 2025
Primary outcome: Primary: Surgeon Satisfaction Survey — 4; 4; 4; 4 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
TauTona Pneumoperitoneum Assist Device (TPAD) (Device); Standard of Care (SOC) (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Surgeon Satisfaction Survey		 4; 4; 4; 4; 4; 4 —
SECONDARY
Time From Incision for Veress Needle Insertion to Start of Insufflation		 87.0; 92.0 —
SECONDARY
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0		 0; 0 —

Summary

The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.

Eligibility Criteria

Inclusion Criteria

  • Age >/= 18
  • Scheduled for laparoscopic surgery
  • Able to understand and willing to sign a written informed consent form

Exclusion Criteria

  • Age < 18
  • Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
  • Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
  • Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
  • Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04392635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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