Trial Outcomes & Findings for Clinical Evaluation of the Levita Robotic Platform (NCT NCT05353777)

NCT ID: NCT05353777

Last Updated: 2025-05-28

Results Overview

Total number of adverse events related to the device.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-05-28

Participant Flow

Participant milestones

Measure	Levita Robotic Platform Levita Robotic Platform: Levita Robotic Platform
Overall Study STARTED	48
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Levita Robotic Platform

Baseline characteristics by cohort

Measure	Levita Robotic Platform n=46 Participants Levita Robotic Platform: Levita Robotic Platform
Age, Continuous	45 years STANDARD_DEVIATION 13.25 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Chile	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Total number of adverse events related to the device.

Outcome measures

Measure	Levita Robotic Platform n=46 Participants Levita Robotic Platform: Levita Robotic Platform
Adverse Events Related to the Device	3 Adverse events related to device

SECONDARY outcome

Timeframe: Interoperatively

Number of successfully performed surgeries without the need of additional tools.

Outcome measures

Measure	Levita Robotic Platform n=46 Participants Levita Robotic Platform: Levita Robotic Platform
Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon	46 Successfully performed surgeries

SECONDARY outcome

Timeframe: Interoperatively

Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization.

Outcome measures

Measure	Levita Robotic Platform n=46 Participants Levita Robotic Platform: Levita Robotic Platform
Conversion Rate to Open Surgery	0 Converted procedures

Adverse Events

Levita Robotic Platform

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Levita Robotic Platform n=46 participants at risk Levita Robotic Platform: Levita Robotic Platform
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.

Other adverse events

Measure	Levita Robotic Platform n=46 participants at risk Levita Robotic Platform: Levita Robotic Platform
Gastrointestinal disorders Diarrhea	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Gastrointestinal disorders Anal Fissure	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Skin and subcutaneous tissue disorders Ecchymosis	6.5% 3/46 • Number of events 3 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Surgical and medical procedures Short vessel bleeding	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Gastrointestinal disorders Nausea and Vomiting	4.3% 2/46 • Number of events 2 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Musculoskeletal and connective tissue disorders Back Pain	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Surgical and medical procedures Liver Capsule Minor Abrasion	6.5% 3/46 • Number of events 3 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Skin and subcutaneous tissue disorders Allergy Rush	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Skin and subcutaneous tissue disorders Petechia	4.3% 2/46 • Number of events 2 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.
Skin and subcutaneous tissue disorders Hematoma	2.2% 1/46 • Number of events 1 • Adverse events were documented throughout the course of the study up to thirty (30) days post op.

Additional Information

Vivian Soto

Levita Magnetics

Phone: +56958360507

Email: VSoto@Levita.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place