Device to Assist With Abdominal Access During Laparoscopic Surgery
Not Applicable
Completed
- Conditions
- Laparoscopic Surgery
- Registration Number
- NCT04392635
- Lead Sponsor
- Stanford University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Surgeon Satisfaction Survey up to 1 minute on day of surgery The surgeon completes 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)
- Secondary Outcome Measures
Name Time Method Time From Incision for Veress Needle Insertion to Start of Insufflation Up to approximately 2 minutes Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Continuous from start of surgery through postoperative day 7 Adverse events related to use of the TPAD device
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does the TauTona Pneumoperitoneum Assist Device (TPAD) utilize to enhance peritoneal access during laparoscopic procedures?
How does the TPAD compare to standard-of-care techniques in terms of complication rates and trocar placement efficiency in laparoscopic surgery?
Are there specific biomarkers or patient characteristics that could predict optimal outcomes with TPAD-assisted pneumoperitoneum in abdominal surgeries?
What are the potential adverse events associated with TPAD use and how do they compare to traditional Veress needle and trocar insertion methods in laparoscopic settings?
What are the current trends in pneumoperitoneum device development, and how does the TPAD from Stanford University fit within this landscape of surgical innovation?
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States
Stanford University🇺🇸Stanford, California, United States