Colorectal Procedures Clinical Trial
Official title:
Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System
| NCT number | NCT03960684 |
| Other study ID # | CP006 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 25, 2019 |
| Est. completion date | December 9, 2019 |
| Verified date | May 2024 |
| Source | Levita Magnetics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 9, 2019 |
| Est. primary completion date | December 9, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Chile | Hospital del Salvador | Santiago |
| Lead Sponsor | Collaborator |
|---|---|
| Levita Magnetics |
Chile,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number and types of tools required to retract the colon or peri-colorectal tissues | Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract these tissues during the procedure. | During planned colorectal procedure | |
| Primary | Device related Adverse events | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Through 30 days post colorectal procedure/study completion. |