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| Name | Class |
|---|---|
| TauTona Group | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TauTona Pneumoperitoneum Assist Device (TPAD) | Device | The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 1 minute on day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Adverse events related to use of the TPAD device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R Korndorffer Jr, MD MHPE FACS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) | Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation. |
| FG001 | TauTona Pneumoperitoneum Assist Device (TPAD) | Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed the protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) | Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation. |
| BG001 | TauTona Pneumoperitoneum Assist Device (TPAD) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants who completed the protocol | Posted | Median | Full Range | score on a scale | up to 1 minute on day of surgery |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SOC) | Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fluid Collection | Surgical and medical procedures | Systematic Assessment | Fluid collection in the gallbladder fossa with possible fistulization to the duodenum |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Surgical and medical procedures | Systematic Assessment | Bruising surrounding the Veress needle insertion site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Stanford University | 650-723-6189 | smeyer27@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2024 | Jun 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 19, 2024 | Jun 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care (SOC) | Procedure | Standard of Care was used for Veress needle insertion. |
|
| Continuous from start of surgery through postoperative day 7 |
Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Count of Participants | Participants |
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| Skin Striae Severity | Mild: Few striae, relatively small in size, and may be slightly discolored. Moderate: More numerous striae, slightly wider, and may be a more noticeable color. Severe: Many striae, wider, and may be a more prominent color (red, purple, or white). Extremely Severe: Extensive striae covering a large area, wide, and deeply colored (red, purple, or white). | Count of Participants | Participants |
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| Secondary | Time From Incision for Veress Needle Insertion to Start of Insufflation | Participants who completed the protocol | Posted | Median | Inter-Quartile Range | seconds | Up to approximately 2 minutes |
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| Secondary | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Adverse events related to use of the TPAD device | Posted | Count of Participants | Participants | Continuous from start of surgery through postoperative day 7 |
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| 0 |
| 15 |
| 0 |
| 15 |
| 14 |
| 15 |
| EG001 | TauTona Pneumoperitoneum Assist Device (TPAD) | Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed. | 0 | 16 | 1 | 16 | 14 | 16 |
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