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

NCT07746531 | Not Yet Recruiting

• 1 other identifier: 2025-05
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hysterectomy, Benign Uterine Diseases

Outcome Measures

Primary Outcomes (2)

• Primary safety outcome

  Occurrence of Clavien-Dindo grades III-V adverse events

  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

  Intraoperative

Interventions

benign hysterectomy DEVICE

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

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing a hysterectomy for benign disease

You may qualify if:

• 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

You may not qualify if:

• Any planned concomitant procedures (not including salpingectomy and/or oophorectomy)
• Diagnosed malignant disease on reproductive organs
• Uterus myomatous with fibroid \> 10cm

Sponsors & Collaborators

• Distalmotion SA: lead

Study Sites (2)

Cypress surgery center

Wichita, Kansas, 67226, United States

Location

Memorial Hermann-Texas Medical Center - UT Health Houston

Houston, Texas, 77030-1501, United States

Location

Central Study Contacts

Pascal Lehmann

CONTACT

+41215105890; pascal.lehmann@distalmotion.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

US (2)