Laparoscopic SurgeryNCT04392635
Device to Assist With Abdominal Access During Laparoscopic Surgery
A study testing TauTona Pneumoperitoneum Assist Device (TPAD) in people with Laparoscopic Surgery, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- TauTona Pneumoperitoneum Assist Device (TPAD)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >/= 18
- Scheduled for laparoscopic surgery
- Able to understand and willing to sign a written informed consent form
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
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.
- Conditions
- Laparoscopic Surgery
- Being tested
- TauTona Pneumoperitoneum Assist Device (TPAD), Standard of Care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauTona Pneumoperitoneum Assist Device (TPAD)Device
The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.
Standard of Care (SOC)Procedure or surgery
Standard of Care was used for Veress needle insertion.
| Study group | Role | What they receive |
|---|---|---|
| TauTona Pneumoperitoneum Assist Device (TPAD) | Experimental | Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed. Receives: Device: TauTona Pneumoperitoneum Assist Device (TPAD) |
| Standard of Care (SOC) | Active comparator | Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veress needle was in the correct location (e.g. drop test), insufflation was initiated. Receives: Procedure: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon Satisfaction Survey
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)
Measured: up to 1 minute on day of surgery
Secondary outcomes (2)
Time From Incision for Veress Needle Insertion to Start of Insufflation
Measured: Up to approximately 2 minutes
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Adverse events related to use of the TPAD device
Measured: Continuous from start of surgery through postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 Jun 2022
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- TauTona Group
- Responsible party
- Sponsor
- Investigators
- James R Korndorffer Jr, MD MHPE FACS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392635
- Sponsor's protocol ID
- IRB-55013
- Status last verified
- Jun 2025
- First submitted
- 13 May 2020
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04392635
- Acronym / sponsor ID
- IRB-55013
- Conditions
- Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- TauTona Group
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TauTona Pneumoperitoneum Assist Device (TPAD) | Experimental | Device: TauTona Pneumoperitoneum Assist Device (TPAD)Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed. |
| Standard of Care (SOC) | Active comparator | Procedure: Standard of Care (SOC)Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veress needle was in the correct location (e.g. drop test), insufflation was initiated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 18
- Scheduled for laparoscopic surgery
- Able to understand and willing to sign a written informed consent form
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TauTona Pneumoperitoneum Assist Device (TPAD)The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery. | Device | TauTona Pneumoperitoneum Assist Device (TPAD) |
| Standard of Care (SOC)Standard of Care was used for Veress needle insertion. | Procedure or surgery | Standard of Care (SOC) |
Primary outcome
Surgeon Satisfaction Survey
Time frame: 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)
2 secondary outcomes
Time From Incision for Veress Needle Insertion to Start of Insufflation
Time frame: Up to approximately 2 minutes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Surgery
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Not yet recruiting
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
Medical Education
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Korndorffer Jr, MD MHPE FACS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TauTona Pneumoperitoneum Assist Device (TPAD) in people with Laparoscopic Surgery, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Satisfaction Survey (time frame: up to 1 minute on day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.