Clinical Investigation of the da Vinci Surgical System

Not Applicable

Active, not recruiting

• Conditions: Pelvic Organ Prolapse; Inguinal Hernia; Thymoma; Prostate Disease; Obesity, Morbid; Gynecologic Disease; Gynecologic Cancer; Prostate Cancer; Mediastinal Tumor; Ventral Hernia
• Interventions: Device: Robotic-assisted Surgery

• Registration Number: NCT05682742
• Lead Sponsor: Intuitive Surgical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-12
• Primary Completion: 2023-05-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 53

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic-assisted surgery	Robotic-assisted Surgery	Subjects scheduled to undergo robotic-assisted surgery

Primary Outcome Measures

Name	Time	Method
Incidence of conversion	Intra-operative	Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	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.

Trial Locations

Locations (4)

Orlando Health, Inc.; 🇺🇸 Orlando, Florida, United States

Sparrow Health System; 🇺🇸 Lansing, Michigan, United States

The Valley Hospital; 🇺🇸 Ridgewood, New Jersey, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States