ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM
Distalmotion SA
Summary
The purpose of this post-market, observational study is to collect real-world data under anticipated conditions of use that demonstrates that the device performs as intended (accurate, precise control of surgical instruments) in patients undergoing robotic-assisted and laparoscopic hysterectomy for benign disease.
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patient is ≥ 22 years of age at time of enrollment/consent * Patient is planned to undergo robotic-assisted and laparoscopic hysterectomy for benign disease * Patient agrees to perform the 6-week follow-up assessment as per standard of care Exclusion Criteria: * Any planned concomitant procedures (not including salpingectomy and/or oophorectomy) * Diagnosed malignant disease on reproductive organs * Uterus myomatous with fibroid \> 10cm
Interventions
- Devicebenign hysterectomy
Robotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system.
Locations (2)
- Cypress surgery centerWichita, Kansas
- Memorial Hermann-Texas Medical Center - UT Health HoustonHouston, Texas