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Clinical Trials/NCT05682742
NCT05682742
Active, Not Recruiting
N/A

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

Intuitive Surgical4 sites in 1 country53 target enrollmentDecember 12, 2022
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ConditionsThymomaMediastinal TumorGynecologic DiseaseGynecologic CancerPelvic Organ ProlapseProstate DiseaseProstate CancerInguinal HerniaVentral HerniaObesity, Morbid

Overview

Phase
N/A
Intervention
Not specified
Conditions
Thymoma
Sponsor
Intuitive Surgical
Enrollment
53
Locations
4
Primary Endpoint
Incidence of conversion
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2022
End Date
August 31, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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(30-day follow-up)

Study Sites (4)

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