Hysterectomy, Partial Nephrectomy, Right Colectomy
Conditions
Brief summary
The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).
Interventions
DEVICErobotic-assisted surgery
Gynecology: robot-assisted and laparoscopic hysterectomy for benign or low risk malignant disease
Sponsors
Distalmotion SA
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Aged ≥ 18 years * Patient agrees to perform the 30-day follow-up assessment * Able to provide signed Informed Consent, according to local regulation
Exclusion criteria
* Morbidly obese patients. * Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments. * Bleeding diathesis. * Pregnancy. * Patients with pacemakers or internal defibrillators. * Any planned concomitant procedures. * Patient deprived of liberty by administrative or judicial decision or under legal guardianship. * Participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of serious (Clavien - Dindo grades III-V), device related adverse events. | perioperatively up to 30 days |
| successful completion of the Dexter-assisted procedure, i.e. free of any device related permanent conversion to an open or fully laparoscopic surgical approach. | intraoperative |
Countries
France, Germany, Switzerland
Outcome results
None listed