18 and older, any sex, with Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number and Types of Additional Tools Required to Mobilize the Liver During ProcedurePrimary· During planned bariatric procedure. (approximately 2 hours on a single day.)
The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful.
Group
Value
95% CI
Intervention
0
Number of Participants With Adverse Events and Device Related Adverse EventsPrimary· Through 30 days post bariatric procedure
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Total Participants With Adverse Events
Group
Value
95% CI
Intervention
17
Participants With Adverse Events Related to Device
Group
Value
95% CI
Intervention
14
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Intervention
Serious: 2/54 (4%)
Deaths: 0/54
Serious adverse events (2 terms)
Reaction
System
Intervention
Miscarriage
Pregnancy, puerperium and perinatal conditions
—
Abdominal Pain and Vomiting
Gastrointestinal disorders
—
Other adverse events (6 terms — click to expand)
Reaction
System
Intervention
Petechiae
Skin and subcutaneous tissue disorders
—
Liver Capsule Superficial Erosion Without Bleeding
Hepatobiliary disorders
—
Liver Capsule Superficial Abrasion Without Bleeding
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07293611 — A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in La
· NA
· not yet recruiting
NCT03960684 — Study of Colorectal Procedures With the Levita Magnetic Surgical System
· NA
· completed
NCT03624465 — Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
· NA
· completed
Other recruiting trials for Bariatric Surgery Candidate
Currently open trials in the same condition.
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· NA
· recruiting
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NCT06915558 — Modulation of the Inflammatory Response in Bariatric Surgery
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NCT06689241 — Rivaroxaban Versus Enoxaparin for Prophylaxis of Venous Thromboembolism in Bariatric Surgery
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Other Levita Magnetics trials
Trials by the same sponsor.
NCT07470411 — Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study
· NA
· not yet recruiting
NCT07293611 — A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in La
· NA
· not yet recruiting
NCT06743256 — Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological
· NA
· terminated
NCT06432088 — Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
· NA
· completed
NCT05695989 — Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparosc
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Levita Magnetics
Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03508674.