Clinical Investigation of the da Vinci Surgical System

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05682742
• Other study ID #: 1097341C
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2024
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: August 31, 2028
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Cancer
• Gynecologic Disease
• Hernia
• Hernia, Inguinal
• Hernia, Ventral
• Inguinal Hernia
• Mediastinal Neoplasms
• Mediastinal Tumor
• Obesity, Morbid
• Pelvic Organ Prolapse
• Prolapse
• Prostate Cancer
• Prostate Disease
• Prostatic Diseases
• Thymoma
• Ventral Hernia

Intervention

Device:
• Robotic-assisted Surgery
Subjects scheduled to undergo robotic-assisted surgery

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Sparrow Health System	Lansing	Michigan
United States	Orlando Health, Inc.	Orlando	Florida
United States	The Valley Hospital	Ridgewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of conversion	Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.	Intra-operative
Secondary	Incidence of adverse events	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