A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreati… (NCT06562179) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
United States35 participantsStarted 2024-05-14
Plain-language summary
The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Cholecystectomy Stage 1 - Inclusion Criteria:
* Patients between the ages of 18 and 80 years of age
* Either male or female
* BMI ≤ 26 kg/m2
* ASA ≤ 3
* Diagnosed with benign disease
Fundoplication Stage 1- Inclusion Criteria:
* Patients diagnosed with GERD and/or hiatal hernia
* Patients between the ages of 18 and 80 years of age
* Either men or women
* BMI ≤ 26 kg/m2
* ASA ≤ 3
Gastrectomy Stage 2- Inclusion Criteria:
* Patients between the ages of 18 and 80 years of age
* Either men or women
* BMI ≤ 26 kg/m2
* ASA ≤ 3
* Diagnosed with benign or relatively early malignant disease of the stomach
* AJCC 8th edition T0 or T1 tumor pathology
* AJCC 8th edition T2, T3, tumor pathology (following neoadjuvant therapy if necessary) at the discretion of the investigator
* Free of metastatic disease
Distal Pancreatectomy Stage 2- Inclusion Criteria:
* Patients between the ages of 18 and 80 years of age
* Either men or women
* BMI ≤ 26 kg/m2
* ASA ≤ 3
* Diagnosed with benign or malignant disease of the pancreas
* No vascular involvement
* Free of metastatic disease
Pancreaticoduodenectomy Stage 3- Inclusion Criteria:
* Patients between the ages of 18 and 80 years of age
* Either men or women
* BMI ≤ 26 kg/m2
* ASA ≤ 3
* Diagnosed with benign or malignant disease of the pancreas
* Diagnosed with benign or malignant distal bile duct disease
* No vasculature involvement (i.e., no T4 disease, pancreatic or Stage 4a or b disease, or distal bile duct Stage 3b or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Completion Using the planned da Vinci SP-assisted Single Port Robot.