Laparoscopic Surgery
Conditions
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.
Interventions
DEVICETauTona Pneumoperitoneum Assist Device (TPAD)
The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.
PROCEDUREStandard of Care (SOC)
Standard of Care was used for Veress needle insertion.
Sponsors
TauTona Group
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| TauTona Pneumoperitoneum Assist Device (TPAD) Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Total | TauTona Pneumoperitoneum Assist Device (TPAD) | Standard of Care (SOC) |
|---|---|---|---|
| Age, Customized 18-40 years old | 6 Participants | 4 Participants | 2 Participants |
| Age, Customized 41-64 years old | 12 Participants | 3 Participants | 9 Participants |
| Age, Customized 65 and over | 12 Participants | 8 Participants | 4 Participants |
| Body Mass Index (BMI) 18.5-24.9 kg/m^2 | 8 Participants | 5 Participants | 3 Participants |
| Body Mass Index (BMI) 25.0-29.9 kg/m^2 | 12 Participants | 6 Participants | 6 Participants |
| Body Mass Index (BMI) 30.0-34.9 kg/m^2 | 10 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian; Non-Hispanic/Non- Latino | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 11 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized White; Non-Hispanic/Non- Latino | 15 Participants | 8 Participants | 7 Participants |
| Region of Enrollment United States | 30 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Female | 18 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 12 Participants | 4 Participants | 8 Participants |
| Skin Striae Severity Extremely Severe | 0 Participants | 0 Participants | 0 Participants |
| Skin Striae Severity Mild | 14 Participants | 7 Participants | 7 Participants |
| Skin Striae Severity Moderate | 5 Participants | 3 Participants | 2 Participants |
| Skin Striae Severity None | 9 Participants | 4 Participants | 5 Participants |
| Skin Striae Severity Severe | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 14 / 15 | 14 / 16 |
| serious Total, serious adverse events | 0 / 15 | 1 / 16 |
Outcome results
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)
Time frame: up to 1 minute on day of surgery
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care (SOC) | Surgeon Satisfaction Survey | Advancing the Veress Needle into the peritoneal cavity was straightforward | 4 score on a scale |
| Standard of Care (SOC) | Surgeon Satisfaction Survey | Inserting the Veress needle could be done by one physician | 4 score on a scale |
| Standard of Care (SOC) | Surgeon Satisfaction Survey | The Veress Needle was accurately inserted | 4 score on a scale |
| Standard of Care (SOC) | Surgeon Satisfaction Survey | Initiating and completing insufflation was straightforward | 4 score on a scale |
| Standard of Care (SOC) | Surgeon Satisfaction Survey | Advancing the Veress Needle into the peritoneal cavity was safe | 4 score on a scale |
| Standard of Care (SOC) | Surgeon Satisfaction Survey | Obtaining counter traction for the Veress Needle was straightforward | 4 score on a scale |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Surgeon Satisfaction Survey | The Veress Needle was accurately inserted | 4 score on a scale |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Surgeon Satisfaction Survey | Obtaining counter traction for the Veress Needle was straightforward | 4 score on a scale |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Surgeon Satisfaction Survey | Advancing the Veress Needle into the peritoneal cavity was straightforward | 4 score on a scale |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Surgeon Satisfaction Survey | Advancing the Veress Needle into the peritoneal cavity was safe | 4 score on a scale |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Surgeon Satisfaction Survey | Inserting the Veress needle could be done by one physician | 4 score on a scale |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Surgeon Satisfaction Survey | Initiating and completing insufflation was straightforward | 4 score on a scale |
Secondary
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Adverse events related to use of the TPAD device
Time frame: Continuous from start of surgery through postoperative day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
Secondary
Time From Incision for Veress Needle Insertion to Start of Insufflation
Time frame: Up to approximately 2 minutes
Population: Participants who completed the protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care (SOC) | Time From Incision for Veress Needle Insertion to Start of Insufflation | 87.0 seconds |
| TauTona Pneumoperitoneum Assist Device (TPAD) | Time From Incision for Veress Needle Insertion to Start of Insufflation | 92.0 seconds |