Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
Phase: NA
Conditions: Laparoscopic Surgery
Sponsor: Stanford University

 
Pilot Study to Establish Safety and Ease of Use of a 
TauTona Pneumoperitoneum Assist Device (TPAD) 
for Laparoscopic Surgery 
 
NCT04392635 
January 16, 2024 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
The purpose of this study is to assess the safety and ease of use of a trocar placement 
access device (TPAD, Tautona) for laparoscopic surgery. 10 patients will undergo 
laparoscopic surgery as planned, with their surgeon using the TPAD device to guide 
Veress needle insertion and primary trocar placement while gaining access to the 
peritoneal cavity. Surgeons will complete a questionnaire following use of the TPAD to 
evaluate the device feasibility. Ten patients will undergo standard of care without use of 
the TPAD device and also complete surveys. 
b. 
Objectives 
We hope to assess device feasibility and efficacy of the Tautona TPAD for clinical use. 
c. 
Rationale for Research in Humans 
The purpose of the study is to measure ease-of-use by surgeons in human patients. 
therefore, human patients are needed. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
Surgeons will identify patients scheduled to undergo laparoscopic surgery procedures and 
notify study staff. The patient will be met in the pre- operative holding area and informed 
consent will be obtained. 
 
Patients will be randomized via block randomization. 
 
Clinical information will be collected from participating patients 
including age, sex, demographic, past medical and surgical history, medications, 
allergies, diagnosis, and planned procedure. Clinical data will be de- identified and stored 
on a password protected spreadsheet on a PHI- safe server. 

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The surgeon will utilize the TPAD device to assist with Veress needle insertion (standard 
of care) to obtain access to the peritoneal cavity. The device will also be used to guide 
primary trocar placement. 
 
Following induction of general anesthesia, the patient is prepped and draped in sterile 
fashion. Local anesthetic is infiltrated at the planned incision site and an incision is made 
with a scalpel. These steps are the same in any laparoscopic procedure. Next, the sterile 
TPAD, which is connected to a suction source, is centered over the incision, and the 
suction cups activated to non-invasively grasp the skin. The TPAD is pulled upward, and 
the Veress needle is advanced through the incision into the peritoneal cavity. Once the 
needle enters the cavity, the abdomen is insufflated as per usual standard of care. Once 
insufflated, the veress needle is withdrawn while maintaining the TPAD's suction on the 
skin. The primary trocar is then advanced through the incision into the abdominal cavity. 
The suction is then released and the TPAD taken away from the operating field. 
 
The time needed to obtain laparoscopic access and the time needed for trocar placement 
will be recorded. Non-identifiable photos and/or video may be taken of the TPAD device 
during use. Acquired digital images may capture a portion of the patient's skin, however 
if a patient has any identifying features such as scars or tattoos, these areas will be 
cropped out of the images, or if this is not possible, no images will be recorded of that 
patient. There will be no other alterations to the planned surgery and it will proceed as 
planned. Following surgery, the surgeon will complete a questionnaire. Any adverse 
events will be recorded by medical record review. 
 
Patients will undergo routine postoperative care as indicated by their surgery. no 
additional visits will be required due to their being enrolled in the study. The patient will 
participate in a questionnaire and may take non-identifiable photographs of the portion of 
the patients skin where the TPAD device acts, as described above. 
b. 
Procedure Risks 
Testing this device in human patients is necessary to establish its feasibility in a clinical 
setting. Identifying a safe, quicker method for obtaining peritoneal access has the 
potential to improve care for patients. 
c. 
Use of Deception in the Study 
No deception will be used. 
d. 
Use of Audio and Video Recordings 
Non-identifiable digital photos and/or videos will be taken of the TPAD during use and 
post-operatively. Acquired digital images may capture a portion of the patient's skin, 
however if a patient has any identifying features such as scars or tattoos, these areas will 
be cropped out of the images, or if this is not possible, no images will be recorded of that 
patient. Images will be kept on an encrypted, secure server, accessible only to study 
personnel. Some of these images may be used for publication or shared with the sponsor 
for providing instruction for other surgeons. Any images not used for these purposes will 
be erase. 

January 16, 2024 
 
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e. 
Alternative Procedures or Courses of Treatment 
The alternative is to not participate. No standard treatments will be withheld as a result of 
participating in the trial. Typically, surgeons use a Veress or Hasson technique to obtain 
laparoscopic peritoneal access. The risks and benefits are the same for all laparoscopic 
access techniques. The benefit of laparoscopic surgery over open surgery includes 
smaller incisions/scars, less postoperative pain and faster recovery, and reduced risk for 
incisional hernia 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
Yes 
g. 
Study Endpoint(s) 
The study will terminate after 10 patients have been enrolled and have undergone surgery 
with use of the study device and 10 patients have undergone the standard of care and 
completed the survey. The primary outcome measure is device feasibility as measured by 
a surgeon questionnaire, which is completed at the end of every surgery. Secondary 
outcome measures include the time needed to obtain laparoscopic access using the 
device, as well as monitoring for adverse events. Another secondary outcome measure 
includes patient questionnaire to assess satisfaction. 
 
If there is clear evidence of a lack of device feasibility through surgeon questionnaire 
review, or if there are any adverse events recorded that are related to the device and 
which endanger the health of a patient, the project leader will evaluate this information 
and decide whether any modifications or termination of the protocol are indicated. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Gaining laparoscopic access to the abdomen is a clinical challenge 
due to 
the nature of inserting surgical instruments through small incisions. 
Laparoscopic entry is a blind procedure and thus it is not surprising 
that at 
least 50% of major complications of laparoscopic surgery occur prior 
to the 
commencement of the intended surgery. This complication rate has 
remained stable for the past 25 years. The Hasson technique (open) is 
considered safer, but is more time consuming with an average access 
time 
of 3-10 minutes (Hasson 1999). The Veress technique is a blind 
technique 
that has the advantage of being faster, however carries a risk of 
major 
vascular injury during insertion (Sangrasi et al, 2011). It is 
critical during 

January 16, 2024 
 
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Veress needle access to upward tension on the abdominal wall so as to 
increase the distance between the abdominal wall fascia and major 
abdominal blood vessels. In order to address this need, Tautona 
developed 
the TPAD, a device which applies suction to the abdominal wall skin 
to 
facilitate easy upward traction during Veress needle insertion, thus 
improving speed and safety of peritoneal access. 
 
Sangrasi et al. A safe quick technique for placement of the first access port for creation of 
pneumoperitoneum. Journal of the Society of Laparoscopic and Robotic Surgeons. 2011 
 
Hasson HM. Open laparoscopy as a method of access in laparoscopic surgery. Gynaecol 
Endosc. 1999;8:353–62. 
b. 
Findings from Past Animal Experiments 
N/A 
4. 
RADIOISOTOPES USED IN THE STUDY 
N/A 
5. 
DEVICES USED IN THE STUDY 
a. 
Investigational Devices (Including Commercial Devices Used Off-Label) 
Investigational Device 1 
Name: 
Trocar placement access device (TPAD) 
Description: 
The TPAD can be used to assist in the passage of a Veress Needle to 
establish a pneumoperitoneum for laparoscopic surgical procedures. The 
TPAD can also be used to place the Primary Trocar, once the 
pneumoperitoneum has been achieved. The TPAD is comprised of 1) a 
pad with suction cups throughout the bottom surface, 2) a port with which 
to connect to a line coming from a sterile central vacuum source (central 
vacuum line), 3) a feature to activate or deactivate the central vacuum 
line, and 4) a handle to manipulate the TPAD when suctioned to skin. The 
pad has a middle layer that distributes the vacuum from the central 
vacuum line to each of the suction cups. 
Significant Risk? (Y/N) 
No 
Rationale for Non-Significant Risk 
The device applies suction via small vacuum powered suction cups to the 
abdominal wall skin. the risk of injury due to use of the device is minimal. 
Peritoneal access is still achieved using a Veress needle, which is the 
standard of care. 
 
b. 
IDE-Exempt Devices 
N/A 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
N/A 

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7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
N/A 
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
(i) 30 
(ii) 30 
(iii) participants are patients undergoing laparoscopic surgery. The indications for 
laparoscopic surgery are very broad and include appendicitis, gallbladder disease, 
inflammatory bowel disease, cancer, and others. 
b. 
Age, Gender, and Ethnic Background 
Patients >/= 18 years old of any gender and ethnicity will be recruited. 
c. 
Vulnerable Populations 
Patients who are economically/educationally disadvantaged, homeless, employees or 
students may be candidates to participate in the study. We will make it clear that 
participation is voluntary, that no part of their care is contingent on participating, and that 
there will be no compensation for participating. Decisionally impaired patients will not 
be included. Children and pregnant women will not be included in this pilot study. 
d. 
Rationale for Exclusion of Certain Populations 
No women or minorities will be excluded from participating. Children will not be 
included in this study as the device is primarily intended for use in adult patients. 
e. 
Stanford Populations 
We do not aim to recruit any particular number of laboratory personnel, employees 
and/or students. Participants may fall into these categories purely incidentally. All 
participants receive the same written informed consent. 
f. 
Healthy Volunteers 
There are no healthy volunteers as all participants have a clinical indication for 
undergoing laparoscopic surgery. 
g. 
Recruitment Details 
The surgeon will identify patients scheduled for laparoscopic surgery from their schedule 
and invite them to participate. if they are agreeable, study staff will be notified by the 
surgeon. The study staff will then meet the patient in the pre-operative area before their 
surgery to discuss the study and to obtain consent. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 

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Age >/= 18 
Scheduled for laparoscopic surgery 
Able to understand and willing to sign a written informed consent form 
ii. 
Exclusion Criteria 
Age < 18 
BMI > 35 
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. 
i. 
Screening Procedures 
The surgeon will notify study staff of any patient meeting study inclusion criteria. 
 
No personal health information will be collected prior to enrollment. 
 
A waiver of authorization is provided in section 15. A data privacy attestation has been 
submitted. 
j. 
Participation in Multiple Protocols 
Patients will be asked if they are participating in any other studies prior to obtaining 
consent. If there is a potential that participation in either study may affect the outcome of 
the other, the patient will not be included. 
k. 
Payments to Participants 
No payment/reimbursement will be given for participation. 
l. 
Costs to Participants 
No additional costs are charged to the patient. the patient is still responsible for the cost 
of surgery. 
m. 
Planned Duration of the Study 
The study duration will be 1 year. 
 
Total time per participant: 
(i) screening: 1 week 
(ii) active participation: <1 day (duration of surgery) 
(iii) analysis of data: 1 month 

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9. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
The TPAD device contacts the abdominal skin through a series of small vacuum powered 
suction cups. These are only in contact with the skin for a few minutes. The risk of 
damage to the skin is minimal.  
 
Obtaining peritoneal access with a Veress needle, as well as laparoscopic surgery in 
general, carries risks including bleeding, damage to underlying structures including injury 
to bowel or major blood vessels, hernia, infection, scarring, pain, need for additional 
procedures.  
 
The risks of laparoscopic surgery include:  
• Infection  
• Bleeding  
• Damage to surrounding structures  
• Need for additional procedures  
• Hernia  
• Pain  
• Scarring  
• Wound healing problems  
 
The risks of veress needle insertion include:  
• failed entry  
• omental injury  
• organ injury  
• insertion site infection  
 
The risks of TPAD include:  
• skin discoloration/bruising 
ii. 
Investigational drugs 
N/A 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
N/A 
iv. 
Procedures 
The TPAD device contacts the abdominal skin through a series of small vacuum powered 
suction cups. These are only in contact with the skin for a few minutes. The risk of 
damage to the skin is minimal. 
 
Obtaining peritoneal access with a Veress needle, as well as laparoscopic surgery in 
general, carries risks including bleeding, damage to underlying structures including injury 

January 16, 2024 
 
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to bowel or major blood vessels, hernia, infection, scarring, pain, need for additional 
procedures. 
 
Health information is collected, and there is a risk of loss of confidentiality. however, this 
risk is low, as this information is kept on encrypted, password-secured servers. 
 
Intra-operative photos/videos taken will similarly be kept on a password protected, 
encrypted server. these images may include a portion of the patient's skin, but this will be 
un-identifiable. If the patient has identifying scars or tattoos, this will be cropped out of 
the images, or, if this is not possible, no images will be stored for that patient. thus, the 
risk of identity exposure from these images is very low. 
v. 
Radioisotopes/radiation-producing machines 
N/A 
vi. 
Physical well-being 
The TPAD device contacts the abdominal skin through a series of small vacuum powered 
suction cups. These are only in contact with the skin for a few minutes. The risk of 
damage to the skin is minimal. 
 
Obtaining peritoneal access with a Veress needle, as well as laparoscopic surgery in 
general, carries risks including bleeding, damage to underlying structures including injury 
to bowel or major blood vessels, hernia, infection, scarring, pain, need for additional 
procedures. 
vii. 
Psychological well-being 
N/A 
viii. 
Economic well-being 
N/A 
ix. 
Social well-being 
N/A 
x. 
Overall evaluation of risk 
Medium 
b. 
International Research Risk Procedures 
N/A 
c. 
Procedures to Minimize Risk 
Risks will be minimized by adhering to the inclusion/exclusion criteria. 
 
Postoperatively, patients will be cared for by the Stanford general surgery service which 
has expertise in the management of patients undergoing laparoscopic surgery. 

January 16, 2024 
 
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All clinical data and images will be stored on an encrypted server. If the patient has 
identifying scars or tattoos, this will be cropped out of the images, or, if this is not 
possible, no images will be stored for that patient. All data will be coded with an assigned 
study number. The study key will be kept in a password protected file that will be deleted 
at the conclusion of the study. 
d. 
Study Conclusion 
The experiment terminates for each participant at the end of their surgery. no additional 
follow up is needed. the general surgery service will care for the patients post-operatively 
and manage any adverse events that may occur. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
Aggregate Data Analysis 
Progress toward Study endpoint(s) 
AEs, SAEs, SUSARs 
Participant consent forms 
ii. 
Person(s) responsible for Data and Safety Monitoring 
The PD will be responsible for Data and Safety Monitoring. 
iii. 
Frequency of DSMB meetings 
N/A 
10. 
BENEFITS 
We anticipate the TPAD could save anywhere from 1 to 10 minutes of anesthesia time. the 
patient may therefore benefit from shorter operative time (shorter duration of anesthesia). There 
could additionally be significant cost savings with shorter anesthesia. For example, the average 
cost for running an OR has been estimated at $62/minute, not counting personnel costs including 
Anesthesia fees. Therefore, we anticipate the potential for significant time and cost savings. 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.