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

N/ANot Yet RecruitingNCT07746531

Distalmotion SA112 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

112

Conditions

Hysterectomy, Benign Uterine Diseases

Interventions

benign hysterectomyDEVICE

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

Eligibility

Sex: FEMALEMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

Cypress surgery center

Wichita, Kansas, United States

Memorial Hermann-Texas Medical Center - UT Health Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Primary safety outcome

Occurrence of Clavien-Dindo grades III-V adverse events

Time frame: 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

Time frame: Intraoperative

Central Contacts

Pascal Lehmann

CONTACT

+41215105890 pascal.lehmann@distalmotion.com

Data from ClinicalTrials.gov

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