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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM
- ClinicalTrials.gov ID
- NCT07746531
- Acronym / sponsor ID
- MAGENTA / 2025-05
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing a hysterectomy for benign disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Any planned concomitant procedures (not including salpingectomy and/or oophorectomy)
- Diagnosed malignant disease on reproductive organs
- Uterus myomatous with fibroid > 10cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benign hysterectomyRobotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system. | Device | – |
Primary outcome
Primary safety outcome
Time frame: up to 42 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
Time frame: Intraoperative
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, Benign Uterine Diseases, run by Distalmotion SA at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal Lehmann (+41215105890, pascal.lehmann@distalmotion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety outcome (time frame: up to 42 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.