Trial Outcomes & Findings for Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures (NCT NCT05695989)

NCT ID: NCT05695989

Last Updated: 2025-02-21

Results Overview

Adverse events related to the device

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-02-21

Participant Flow

Participant milestones

Measure	DRAA (Dual Robotic Arm Accessory) Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

Baseline characteristics by cohort

Measure	DRAA (Dual Robotic Arm Accessory) n=20 Participants Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 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	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Adverse events related to the device

Outcome measures

Measure	DRAA (Dual Robotic Arm Accessory) n=20 Participants Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.
Adverse Events- Safety	0 Device related adverse events

SECONDARY outcome

Timeframe: Surgery time

Ratio of successful attempts vs unsuccessful attempts

Outcome measures

Measure	DRAA (Dual Robotic Arm Accessory) n=20 Participants Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.
Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon	20 Number Surgeries completed successfully

SECONDARY outcome

Timeframe: Surgery time

Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization

Outcome measures

Measure	DRAA (Dual Robotic Arm Accessory) n=20 Participants Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.
Conversion Rate to Open Surgery	0 Converted procedures

Adverse Events

DRAA (Dual Robotic Arm Accessory)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DRAA (Dual Robotic Arm Accessory) n=20 participants at risk Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.
Skin and subcutaneous tissue disorders Allergic Rash	5.0% 1/20 • Number of events 1 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Skin and subcutaneous tissue disorders Ecchymosis in surgical wound	15.0% 3/20 • Number of events 3 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Surgical and medical procedures Liver capsule minor abrasion without clinically relevant concern	15.0% 3/20 • Number of events 3 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Skin and subcutaneous tissue disorders Petechia	20.0% 4/20 • Number of events 4 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).

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