Trial Outcomes & Findings for Device to Assist With Abdominal Access During Laparoscopic Surgery (NCT NCT04392635)

NCT ID: NCT04392635

Last Updated: 2025-07-01

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: up to 1 minute on day of surgery
• Results posted on: 2025-07-01

Participant Flow

Participant milestones

Measure	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.	TauTona Pneumoperitoneum Assist Device (TPAD) Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Overall Study STARTED	15	16
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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.	TauTona Pneumoperitoneum Assist Device (TPAD) Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Device to Assist With Abdominal Access During Laparoscopic Surgery

Baseline characteristics by cohort

Measure	Standard of Care (SOC) n=15 Participants 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.	TauTona Pneumoperitoneum Assist Device (TPAD) n=15 Participants Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.	Total n=30 Participants Total of all reporting groups
Age, Customized 18-40 years old	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Customized 41-64 years old	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Age, Customized 65 and over	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White; Non-Hispanic/Non- Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian; Non-Hispanic/Non- Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Body Mass Index (BMI) 18.5-24.9 kg/m^2	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Body Mass Index (BMI) 25.0-29.9 kg/m^2	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Body Mass Index (BMI) 30.0-34.9 kg/m^2	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Skin Striae Severity None	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Skin Striae Severity Mild	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Skin Striae Severity Moderate	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Skin Striae Severity Severe	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Skin Striae Severity Extremely Severe	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 minute on day of surgery

Population: Participants who completed the protocol

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)

Outcome measures

Measure	Standard of Care (SOC) n=15 Participants 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.	TauTona Pneumoperitoneum Assist Device (TPAD) n=15 Participants Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Surgeon Satisfaction Survey Obtaining counter traction for the Veress Needle was straightforward	4 score on a scale Interval 3.0 to 4.0	4 score on a scale Interval 4.0 to 4.0
Surgeon Satisfaction Survey Advancing the Veress Needle into the peritoneal cavity was straightforward	4 score on a scale Interval 3.0 to 4.0	4 score on a scale Interval 3.0 to 4.0
Surgeon Satisfaction Survey The Veress Needle was accurately inserted	4 score on a scale Interval 3.0 to 4.0	4 score on a scale Interval 4.0 to 4.0
Surgeon Satisfaction Survey Advancing the Veress Needle into the peritoneal cavity was safe	4 score on a scale Interval 3.0 to 4.0	4 score on a scale Interval 4.0 to 4.0
Surgeon Satisfaction Survey Inserting the Veress needle could be done by one physician	4 score on a scale Interval 2.0 to 4.0	4 score on a scale Interval 3.0 to 4.0
Surgeon Satisfaction Survey Initiating and completing insufflation was straightforward	4 score on a scale Interval 3.0 to 4.0	4 score on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: Up to approximately 2 minutes

Population: Participants who completed the protocol

Outcome measures

Measure	Standard of Care (SOC) n=15 Participants 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.	TauTona Pneumoperitoneum Assist Device (TPAD) n=15 Participants Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Time From Incision for Veress Needle Insertion to Start of Insufflation	87.0 seconds Interval 69.5 to 121.5	92.0 seconds Interval 81.5 to 127.5

SECONDARY outcome

Timeframe: Continuous from start of surgery through postoperative day 7

Adverse events related to use of the TPAD device

Outcome measures

Measure	Standard of Care (SOC) n=15 Participants 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.	TauTona Pneumoperitoneum Assist Device (TPAD) n=16 Participants Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	0 Participants	0 Participants

Adverse Events

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

TauTona Pneumoperitoneum Assist Device (TPAD)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care (SOC) n=15 participants at risk 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.	TauTona Pneumoperitoneum Assist Device (TPAD) n=16 participants at risk Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Surgical and medical procedures Fluid Collection	0.00% 0/15 • 21 days	6.2% 1/16 • Number of events 1 • 21 days

Other adverse events

Measure	Standard of Care (SOC) n=15 participants at risk 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.	TauTona Pneumoperitoneum Assist Device (TPAD) n=16 participants at risk Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.
Surgical and medical procedures Bruising	93.3% 14/15 • Number of events 14 • 21 days	87.5% 14/16 • Number of events 14 • 21 days

Additional Information

Study Team

Stanford University

Phone: 650-723-6189

Email: smeyer27@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place