Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: benign hysterectomy.
- Who it may be relevant to
- Registry conditions: Hysterectomy, Benign Uterine Diseases. Basic parameters: from 22 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM
Overview
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
- Device benign hysterectomy
Robotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system.
Primary outcome measures
- Primary safety outcome [Time frame: up to 42 days after surgery]
- Primary efficacy outcome [Time frame: Intraoperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Cypress surgery center — Wichita
- Memorial Hermann-Texas Medical Center - UT Health Houston — Houston
Identifiers
NCT: NCT07746531 · 2025-05