Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System (MAGENTA)

July 31, 2026 updated by: Distalmotion SA

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Texas
      • Houston, Texas, United States, 77030-1501
        • Memorial Hermann-Texas Medical Center - UT Health Houston
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing a hysterectomy for benign disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary safety outcome
Time Frame: up to 42 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
up to 42 days after surgery
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
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Distalmotion SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 7, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

July 31, 2026

First Posted (Actual)

August 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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