Gynecologic Cancer, Gynecologic Disease, Inguinal Hernia, Mediastinal Tumor, Obesity, Morbid, Pelvic Organ Prolapse, Prostate Cancer, Prostate Disease, Thymoma, Ventral Hernia
Conditions
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.
Interventions
DEVICERobotic-assisted Surgery
Subjects scheduled to undergo robotic-assisted surgery
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of conversion | Intra-operative | Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed