Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age22+
SponsorDistalmotion SA
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Any planned concomitant procedures (not including salpingectomy and/or oophorectomy)
Diagnosed malignant disease on reproductive organs
Uterus myomatous with fibroid > 10cm
Trial design
Treatments tested in this trial
- benign hysterectomy
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov