Clinical Investigation of the da Vinci Surgical System

May 30, 2024 updated by: Intuitive Surgical

A Prospective, Multicenter 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc.
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Health System
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic-assisted surgery
Subjects scheduled to undergo robotic-assisted surgery
Device: Robotic-assisted Surgery
Subjects scheduled to undergo robotic-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intra-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

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 Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

May 24, 2023

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1097341C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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