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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients undergoing a hysterectomy for benign disease
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
benign hysterectomy
DeviceRobotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary safety outcome
Occurrence of Clavien-Dindo grades III-V adverse events
Time frame
up to 42 days after surgery2
Primary efficacy outcome
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: