Hysterectomy, Benign Uterine Diseases
Conditions
Brief 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.
Interventions
DEVICEbenign hysterectomy
Robotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system.
Sponsors
Distalmotion SA
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety outcome | up to 42 days after surgery | Occurrence of Clavien-Dindo grades III-V adverse events |
| Primary efficacy outcome | Intraoperative | Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach |
Countries
United States
Contacts
CONTACTPascal Lehmann
Outcome results
None listed