Clinical Investigation of the da Vinci Surgical System

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Thymoma Body Weight Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Male Gynecologic Cancer Gynecologic Disease Hemic and Lymphatic Diseases Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Ventral Inguinal Hernia Lymphatic Diseases Male Urogenital Diseases Mediastinal Diseases Mediastinal Neoplasms Mediastinal Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Prostate Cancer Prostate Disease Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Signs and Symptoms Thoracic Diseases Thoracic Neoplasms Thymus Neoplasms Urogenital Diseases Urogenital Neoplasms Ventral Hernia

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health, Inc., Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pre-operative Inclusion Criteria:

Age 21 years or older
Per study Investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure

Pre-operative Exclusion Criteria:

Subject is pregnant or suspected to be pregnant or breastfeeding
Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
Subject belongs to vulnerable population.
Subject is contraindicated for anesthesia or surgery
Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months

Treatment and study plan

Robotic-assisted Surgery

Device

Subjects scheduled to undergo robotic-assisted surgery

Primary outcomes

Incidence of conversion

Time frame: Intra-operative

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Secondary outcomes

Incidence of adverse events

Time frame: 30-day follow-up

Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2028
First posted: Jan 12, 2023
Registry last updated: Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed