Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Device to Assist With Abdominal Access During Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392635
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
TauTona Group
Information provided by (Responsible Party):
James Lau, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Surgery Device: Trocar Placement Assist Device (TPAD) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study to Establish Safety and Ease of Use of a Trocar Placement Access Device (TPAD) for Laparoscopic Surgery
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: Trocar Placement Assist Device (TPAD)
Participants will receive investigational TPAD device during laparoscopic surgery
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.




Primary Outcome Measures :
  1. Surgeon satisfaction survey [ Time Frame: up to 1 minute on day of surgery ]
    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)


Secondary Outcome Measures :
  1. Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery [ Time Frame: Up to 10 minutes ]
    Time from incision to successful placement of primary trocar will be measured and reported

  2. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Continuous from start of surgery through postoperative day 7 ]
    Adverse events related to the surgery itself, or to the incision and skin around the incision where the TPAD is placed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392635


Locations
Layout table for location information
United States, California
Stanford Hospital
Stanford, California, United States, 94304
Contact: Study Team    650-736-2776    tcarlomagno@stanford.edu   
Sub-Investigator: Janos Barrera, MD         
Sponsors and Collaborators
James Lau
TauTona Group
Investigators
Layout table for investigator information
Principal Investigator: James Lau, MD Stanford University
Layout table for additonal information
Responsible Party: James Lau, Professory of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04392635    
Other Study ID Numbers: IRB-55013
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes