Device to Assist With Abdominal Access During Laparoscopic Surgery

Laparoscopic Surgery Clinical Trial

Official title:

Pilot Study to Establish Safety and Ease of Use of a Trocar Placement Access Device (TPAD) for Laparoscopic Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04392635
• Other study ID #: IRB-55013
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Device:
• Trocar Placement Assist Device (TPAD)
The TPAD is an experimental device used to assist with placement of Veress needle and trocar during laparoscopic surgery.

Locations

Country	Name	City	State
United States	Stanford Hospital	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	TauTona Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon satisfaction survey	The surgeon will complete a LIKERT scale satisfaction survey related to the TPAD to assess its ease of use. Scale range 1-5 (higher scores correspond to higher satisfaction)	up to 1 minute on day of surgery
Secondary	Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery	Time from incision to successful placement of primary trocar will be measured and reported	Up to 10 minutes
Secondary	Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Adverse events related to the surgery itself, or to the incision and skin around the incision where the TPAD is placed	Continuous from start of surgery through postoperative day 7