Clinical trial

Clinical Investigation of the da Vinci Surgical System

Active, not recruiting ยท Not applicable ยท 1 countries ยท Registry ID NCT05682742

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionThymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer, Pelvic Organ Prolapse, Prostate Disease, Prostate Cancer, Inguinal Hernia, Ventral Hernia, Obesity, Morbid

Full registry criteria

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

Treatments and study arms

Robotic-assisted Surgery

Device

Subjects scheduled to undergo robotic-assisted surgery

Primary outcomes

Incidence of conversionIntra-operative

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Study locations

4 locations were listed when this page was built. The first 40 are shown.

The Ohio State University Wexner Medical Center๐Ÿ‡บ๐Ÿ‡ธ Columbus, Ohio, United States
Sparrow Health System๐Ÿ‡บ๐Ÿ‡ธ Lansing, Michigan, United States
Orlando Health, Inc.๐Ÿ‡บ๐Ÿ‡ธ Orlando, Florida, United States
The Valley Hospital๐Ÿ‡บ๐Ÿ‡ธ Ridgewood, New Jersey, United States