N/A
N=31
Study of Colorectal Procedures With the Levita Magnetic Surgical System
Colorectal Procedures
Bottom Line
View on ClinicalTrials.gov: NCT03960684 ↗Enrolled (actual)
31
Serious AEs
13.3%
Results posted
Dec 2024
Primary outcome: Primary: Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues — 0 Cumulative number of additional tools
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levita Magnetic Surgical System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Levita Magnetics
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues |
— | — |
| PRIMARY Device Related Adverse Events |
6 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.
Eligibility Criteria
Inclusion Criteria
- Subject is at least 18 years of age
- Subject is scheduled to undergo elective colorectal surgery
Exclusion Criteria
- Significant comorbidities
- Subjects with pacemakers, defibrillators, or other electromedical implants
- Subjects with ferromagnetic implants
- Clinical history of impaired coagulation
- Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
- Subject is not likely to comply with the follow-up evaluation schedule
- Subject is participating in another clinical trial
Data sourced from ClinicalTrials.gov (NCT03960684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.