TauTona Pneumoperitoneum Assist Device (TPAD)

Stanford University

Status: Active, not recruiting

Conditions: Laparoscopic Surgery

Treatments: Device: Trocar Placement Assist Device (TPAD)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06361849

55013

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental: Trocar Placement Assist Device (TPAD)

Experimental group

Description:

Participants will receive investigational TPAD device during laparoscopic surgery

Treatment:

Device: Trocar Placement Assist Device (TPAD)

Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

Device: Trocar Placement Assist Device (TPAD)