RECRUITING

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.

Quick Facts

Study Start:2024-05-14
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06562179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients between the ages of 18 and 80 years of age
  2. * Either male or female
  3. * BMI ≤ 26 kg/m2
  4. * ASA ≤ 3
  5. * Diagnosed with benign disease
  1. * Subject requiring an emergent operation
  2. * Pregnancy or nursing
  3. * BMI \> 26 kg/m2
  4. * Previous abdominal surgery
  5. * Subjects with malignant disease
  6. * Inability to provide informed consent
  7. * Contraindicated for general anesthesia or minimally invasive surgery

Contacts and Locations

Study Contact

Daniel Robledo, MS
CONTACT
8139716000
daniel.robledo@adventhealth.com

Principal Investigator

Sharona Ross, MD
PRINCIPAL_INVESTIGATOR
AdventHealth

Study Locations (Sites)

AdventhHealth
Tampa, Florida, 33613
United States

Collaborators and Investigators

Sponsor: AdventHealth

  • Sharona Ross, MD, PRINCIPAL_INVESTIGATOR, AdventHealth

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14
Study Completion Date2030-06

Study Record Updates

Study Start Date2024-05-14
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • SP DaVinci
  • Gallbladder removal
  • Esophageal procedures
  • Gastric resections
  • Pancreas procedures
  • Liver procedures

Additional Relevant MeSH Terms

  • Hepatopancreaticobiliary and Foregut Operations