multiple abdominal, thoracic, urological and gynecological surgeries
Conditions
Interventions
Group 1: Adult patients with an indication for laparoscopic or thoracoscopic surgical intervention in urology, abdominal surgery, thoracic surgery or gynecology using the Senhance Surgical Robot Syste
Sponsors
TransEnteric Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - indication for laparoscopic or thoracoscopic surgical intervention which by the discretion of the treating surgeon is to be performed using the Senhance Surgical Robot System - for retrospective data collection: adult patients who have been treated with the support of the Senhance Surgical Robot System and that have agreed to provide their data according to the patient's informed consent - signed and dated patient informed consent
Exclusion criteria
Exclusion criteria: - patients with any contraindication for a laparoscopic / thorascopic surgical procedure - life-threatening disease, which in the investigator's opinion limits the subjects life expectancy to less than 12 months - patient's inability to give informed consent; for example, through disability, inadequate skills of the German language or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, assessed by the incidence and severity of adverse events acutely and through 12-months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, evaluated based on data indicating procedural success, deviations from the planned surgical course including conversions during the procedure to standard laparoscopic surgery, or open surgery. Procedural efficacy will be evaluated using various surgical measures and procedural measures. Patient reported outcomes include pain scores and quality of life. Surgical workload of the operating surgeon will be assessed by questionnaire. | — |
Countries
Austria, Belarus, Croatia, Germany, Lithuania
Contacts
Public ContactFrank Willeke
St. Marien-Krankenhaus Siegen gem GmbH Chirurgische Klinik
Outcome results
None listed