CompletedNot Applicable

A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System

South Korea42 participantsStarted 2023-02-12

Plain-language summary

The goal of this clinical trial is to test the safety and effectiveness of the Medtronic Hugo™ RAS System in patients undergoing a prostatectomy or a cholecystectomy. A minimum of 40 subjects will be enrolled at single site in Republic of Korea: 20 for prostatectomy and 20 for cholecystectomy. All participants will be followed for 30 days (±7 days) post-procedure.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. Adult subjects (22 years old or greater) who are willing to participate and provide informed consent
✓. Subjects indicated for a radical prostatectomy or a cholecystectomy

Exclusion criteria

✕. Patient with a considerable risk for laparoscopic surgery (e.g., severe cardiopulmonary diseases which contraindicated to general anesthesia, uncontrolled coagulopathy, etc.)
✕. Patients requiring urgent surgery
✕. Pregnant or lactating women
✕. Patients with either of followings:
✕. Previous abdominal surgery (open or laparoscopic) within 2 years before enrollment
✕. Concurrent participation in another clinical study that may confound study results
✕. Patient has a condition that could compromise study compliance (e.g., mentally incompetent, alcohol or drug abuse) as determined by the investigator
✕. Subjects who are considered unsuitable to conduct the trial as determined by the investigator

What they're measuring

Completion Rate

Timeframe: 24 hours

Trial details

NCT IDNCT05715827

SponsorMedtronic - MITG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-05

Results submitted2024-08-26

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