Trial Outcomes & Findings for A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System (NCT NCT05715827)

NCT ID: NCT05715827

Last Updated: 2024-11-05

Results Overview

The primary endpoint of this study is the completion rate, which is defined as a proportion of subjects who completed the surgery without conversion due to system serious malfunction, and without any major complications within 24-hour post-surgery.

• Recruitment status: COMPLETED
• Target enrollment: 42 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2024-11-05

Participant Flow

The recruitment period was from February 12, 2023, to May 7th, 2023. Subjects were recruited at Seoul National University Hospital, a major hospital in Seoul, Korea. Enrollment involved 42 subjects, with 20 subjects indicated for robotic-assisted Prostatectomy and 22 subjects indicated for robotic-assisted Cholecystectomy.

After enrollment, two Cholecystectomy subjects exited the study before surgery due to a surgeon's decision and a console communication error. These two subjects did not undergo a procedure with the Hugo™ RAS System and were treated with laparoscopy as Standard-of-care treatment.

Participant milestones

Measure	Robotic Assisted Radical Prostatectomy Robotic-assisted Radical Prostatectomy Patients indicated for Robotic Assisted Surgery (RAS) for a Prostatectomy will have the RAS surgery using the Medtronic Hugo RAS system.	Robotic-assisted Cholecystectomy Robotic-assisted Cholecystectomy Patients indicated for Robotic Assisted Surgery (RAS) for a Cholecystectomy will have the RAS surgery using the Medtronic Hugo RAS system.
Overall Study STARTED	20	22
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Robotic Assisted Radical Prostatectomy Robotic-assisted Radical Prostatectomy Patients indicated for Robotic Assisted Surgery (RAS) for a Prostatectomy will have the RAS surgery using the Medtronic Hugo RAS system.	Robotic-assisted Cholecystectomy Robotic-assisted Cholecystectomy Patients indicated for Robotic Assisted Surgery (RAS) for a Cholecystectomy will have the RAS surgery using the Medtronic Hugo RAS system.
Overall Study Physician Decision	0	1
Overall Study console communication error	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Robotic Assisted Prostatectomy n=20 Participants The study population will consist of patients 22 years of age or older indicated for a robotic assisted prostatectomy with Hugo™ RAS.	Robotic Assisted Cholecystectomy n=20 Participants The study population will consist of patients 22 years of age or older indicated for a robotic assisted cholecystectomy with Hugo™ RAS.	Total n=40 Participants Total of all reporting groups
Age, Continuous	69 years n=20 Participants	58 years n=20 Participants	63 years n=40 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	12 Participants n=20 Participants	12 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=20 Participants	8 Participants n=20 Participants	28 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants
BMI	24.7 kg/m2 n=20 Participants	23.9 kg/m2 n=20 Participants	24.6 kg/m2 n=40 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: For the analysis, we considered the Full Analysis Set (FAS), defined as all enrolled subjects who began the Hugo™ RAS procedure (first skin incision). Subjects who consented but did not reach the first incision were excluded. Those converted to open or conventional surgery, not due to the Hugo™ RAS System, were included in the safety and descriptive analyses but excluded from the primary endpoint analysis.

The primary endpoint of this study is the completion rate, which is defined as a proportion of subjects who completed the surgery without conversion due to system serious malfunction, and without any major complications within 24-hour post-surgery.

Outcome measures

Measure	RAS Prostatectomy n=20 Participants 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 Participants 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Completion Rate	20 Participants	19 Participants

SECONDARY outcome

Timeframe: 30 days

Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy who went under procedure with Hugo RAS System

A proportion of subjects with any post-operative complication within 30-days post-surgery using the investigational device

Outcome measures

Measure	RAS Prostatectomy n=20 Participants 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 Participants 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Overall Complication Rate Through 30-day Post-surgery	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Population: subjects indicated for robotic-assisted Cholecystectomy received surgery with Hugo RAS System

This measure reports the proportion of subjects with post-operative complications classified as Grade 3 or higher by the Clavien-Dindo system within 30 days post-surgery. The Clavien-Dindo system classifies post-operative complications from Grade 1 (minor) to Grade 5 (death).

Grade 1: Minor deviation, no intervention. Grade 2: Requires medication or transfusion. Grade 3: Requires surgical, endoscopic, or radiological intervention. Grade 4: Life-threatening, requires ICU. Grade 5: Death. Higher grades indicate worse outcomes, with Grade 3 or higher classified as "major complications."

Outcome measures

Measure	RAS Prostatectomy n=20 Participants 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 Participants 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Major Complication Rate Through 30-day Post-surgery	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy underwent the procedure with Hugo RAS system

A proportion of subjects hospitalized within 30 days post-surgery

Outcome measures

Measure	RAS Prostatectomy n=20 Participants 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 Participants 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Readmission Rate Through 30-day Post-surgery	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy who underwent procedure with hugo RAS system

A proportion of subjects go through reoperation for the same indication within 30 days post-surgery

Outcome measures

Measure	RAS Prostatectomy n=20 Participants 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 Participants 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Reoperation Rate Through 30-day Post-surgery	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Peri-operative

Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy received a surgery with the Hugo RAS System.

A proportion of subjects with any device deficiency (DD) during robotic assisted surgery using the investigational device

Outcome measures

Measure	RAS Prostatectomy n=20 Participants 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 Participants 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Device Deficiency Rate	10 Participants	3 Participants

Adverse Events

RAS Prostatectomy

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

RAS Cholecystectomy

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	RAS Prostatectomy n=20 participants at risk 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 participants at risk 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
General disorders Asthenia	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Gastrointestinal disorders Small Bowel Nos Perforation	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Gastrointestinal disorders Abdominal wall hematoma	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Hepatobiliary disorders biliary tract disorder	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Vascular disorders Hypertension	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.

Other adverse events

Measure	RAS Prostatectomy n=20 participants at risk 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System.	RAS Cholecystectomy n=20 participants at risk 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system
Gastrointestinal disorders Abdominal Pain	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Gastrointestinal disorders Intra-abdominal hemmorrhage	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Renal and urinary disorders Urinary retention	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Hepatobiliary disorders Cholelithiasis	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
Injury, poisoning and procedural complications Seroma	0.00% 0/20 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.	5.0% 1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery. In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.

Additional Information

Yewon Lee

Medtronic

Phone: 1031132023

Email: yewon.lee@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI cannot publish or disclose study results until a multicenter publication is released. If not published within one year after study completion at all sites, the PI may then publish, subject to review. The PI must submit publications to Medtronic 60 days before submission for review. Medtronic can request removal of Confidential Information, corrections, and may delay publication by up to 90 days to protect intellectual property.
• Publication restrictions are in place

Restriction type: OTHER