Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System | NCT07746531

NCT07746531

Overview

NCT ID: NCT07746531
Lead Sponsor: Distalmotion SAINDUSTRY
Official Title: ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM
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.
Conditions: Hysterectomy, Benign Uterine Diseases
Interventions: benign hysterectomy

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

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