N/A
Completed N=31
Study of Colorectal Procedures With the Levita Magnetic Surgical System
Colorectal Procedures
Source: ClinicalTrials.gov NCT03960684 ↗
Enrolled (actual)
31
Serious AEs
13.3%
Results posted
Dec 2024
Primary outcomePrimary: Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues — 0 Cumulative number of additional tools
Summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.
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 | — |
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. Informational only — not medical advice.