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NCT Number: NCT07746531

Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic 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.

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Key information

Conditions

Hysterectomy, Benign Uterine Diseases

Age range

22 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cypress surgery center, Wichita, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

benign hysterectomy

Device

Robotic-assisted and laparoscopic hysterectomy for benign disease with the DEXTER robotic surgery system.

Primary outcomes

  1. Primary safety outcome

    Time frame: up to 42 days after surgery

    Occurrence of Clavien-Dindo grades III-V adverse events

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Lehmann

CONTACT

[email protected]

+41215105890

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Registry information

Official study title

ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM

Acronym: MAGENTA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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