Hysterectomy, Benign Uterine DiseasesMAGENTANCT07746531
Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System
An observational study of Hysterectomy, Benign Uterine Diseases, run by Distalmotion SA at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Hysterectomy, Benign Uterine Diseases
- What is being tested?
- benign hysterectomy
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2026to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing a hysterectomy for benign disease
Who may be able to join
- 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
Who cannot join
- Any planned concomitant procedures (not including salpingectomy and/or oophorectomy)
- Diagnosed malignant disease on reproductive organs
- Uterus myomatous with fibroid > 10cm
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Memorial Hermann-Texas Medical Center - UT Health Houston
Houston, Texas, 77030-1501
Asha Bhalwal, MD, MRCOG, FACOG, (713)-486-7700, Asha.B.Bhalwal@uth.tmc.edu
Cypress surgery center
Wichita, Kansas, 67226
Zachary Kuhlmann, DO, FACOG, (316) 685-7234, zachary.kuhlmann@awhobgyn.com
About this study
Official title: ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM
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
- Being tested
- benign hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benign hysterectomyDevice
Robotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety outcome
Occurrence of Clavien-Dindo grades III-V adverse events
Measured: up to 42 days after surgery
Primary efficacy outcome
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start7 Aug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterectomy, Benign Uterine DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746531
- Sponsor's protocol ID
- 2025-05
- Acronym
- MAGENTA
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No