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Procedure

Robotic Surgery for Gallbladder Conditions

N/A

Recruiting

Led By Sharona Ross, MD

Research Sponsored by AdventHealth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cholecystectomy Stage 1: Patients between the ages of 18 and 80 years, either male or female, BMI ≤ 26 kg/m2, ASA ≤ 3, diagnosed with benign disease

Fundoplication Stage 1: Patients diagnosed with GERD and/or hiatal hernia, between the ages of 18 and 80 years, either men or women, BMI ≤ 26 kg/m2, ASA ≤ 3

Must not have

Fundoplication Stage 1: Subject requiring an emergent operation, pregnancy or nursing, BMI > 26 kg/m2, previous abdominal surgery, inability to provide informed consent, contraindicated for general anesthesia or minimally invasive surgery

Cholecystectomy Stage 1: Subject requiring an emergent operation, pregnancy or nursing, BMI > 26 kg/m2, previous abdominal surgery, subjects with malignant disease, inability to provide informed consent, contraindicated for general anesthesia or minimally invasive surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to gather information about the safety and effectiveness of using the da Vinci SP Surgical System, Instruments, and Accessories in surgeries involving the liver, pancreas, gallbladder, and stomach.

Who is the study for?

This trial is for individuals needing surgery for certain conditions of the liver, pancreas, gallbladder, stomach, and esophagus. It's not clear what specific criteria must be met or who can't participate without more detailed inclusion and exclusion information.

What is being tested?

The study is testing the da Vinci SP Surgical System in various surgeries like gallbladder removal and stomach surgery to see how safe it is and how well it works.

What are the potential side effects?

Potential side effects are not specified but may include typical risks associated with surgical procedures such as pain, infection, bleeding, or complications related to robotic-assisted operations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-80 years old, with a BMI of 26 or less, and have a benign condition needing gallbladder surgery.

Select...

I am 18-80 years old, with GERD or hiatal hernia, a BMI ≤ 26, and in good health.

Select...

I am 18-80 years old, with a BMI ≤ 26, ASA ≤ 3, and have a pancreatic condition without spread or vascular involvement.

Select...

I am 18-80 years old, with a BMI ≤ 26, ASA ≤ 3, and have a pancreatic or bile duct condition without spread or major blood vessel involvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not require emergency surgery, am not pregnant or nursing, have a BMI ≤ 26, have not had previous abdominal surgery, can consent, and am cleared for general anesthesia and minimally invasive surgery.

Select...

I need an urgent gallbladder removal but I'm not pregnant, nursing, overweight, or have had previous abdominal surgery.

Select...

I am not pregnant, nursing, overweight, or unable to consent, and I have not had previous abdominal surgery.

Select...

I am not pregnant, nursing, overweight, or unable to consent, and I have no prior abdominal surgery or conditions that prevent surgery.

Select...

I am not pregnant, nursing, overweight, or have had previous abdominal surgery. I can consent and am fit for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion Using the planned da Vinci SP-assisted Single Port Robot.

Intraoperative and post-operative adverse events

Number of Lymph node yield

+1 more

Secondary study objectives

30-Day Readmission

30-day complications

Charlson Comorbidity Index Score

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: da Vinci SP® Single-Port Robotic Surgical SystemExperimental Treatment1 Intervention

This study will be separated into four stages, depending on the condition the participant is diagnosed with. Each Participant will go through (1) one operation. Stage One will include five (5) subjects who undergo cholecystectomy and five (5) subjects who undergo hiatal hernia repair with fundoplication (Nissen or Toupet) for a total of ten (10) subjects. Stage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects. Stage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects. Stage Four will include five (5) subjects who undergo hepatectomy

0 / 9Eligibility criteria met