Clinical Investigation of the da Vinci Surgical System
A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System
1 other identifier
interventional
53
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2022
CompletedFirst Submitted
Initial submission to the registry
December 22, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
ExpectedJune 3, 2024
May 1, 2024
5 months
December 22, 2022
May 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of conversion
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
Intra-operative
Secondary Outcomes (1)
Incidence of adverse events
30-day follow-up
Study Arms (1)
Robotic-assisted surgery
EXPERIMENTALSubjects scheduled to undergo robotic-assisted surgery
Interventions
Subjects scheduled to undergo robotic-assisted surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Orlando Health, Inc.
Orlando, Florida, 32806, United States
Sparrow Health System
Lansing, Michigan, 48912, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Merritt RE, Teixeira A, Needleman B, Meara M, Cosgrove C, Sanchez AE, Herrera LJ, Kwasny L, Miller R, Bartley J, Qandeel H, Levy J, Culligan P. A prospective, nonrandomized clinical investigation of the da Vinci surgical system model IS5000. J Robot Surg. 2025 Oct 1;19(1):650. doi: 10.1007/s11701-025-02837-w.
PMID: 41032176DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2022
First Posted
January 12, 2023
Study Start
December 12, 2022
Primary Completion
May 24, 2023
Study Completion (Estimated)
August 31, 2028
Last Updated
June 3, 2024
Record last verified: 2024-05