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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06361849
Other study ID # 55013
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date June 17, 2024

Study information

Verified date March 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 30
Est. completion date June 17, 2024
Est. primary completion date June 17, 2024
Accepts healthy volunteers No
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.

Study Design


Related Conditions & MeSH terms


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 & Clinics Palo Alto 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
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