Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated early by the sponsor due to slow enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Surgical System in laparoscopic gynecological procedures | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical System | Device | Levita Magnetic Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Device and/or Procedure Related Adverse Events | Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity. | From enrollment to end of follow up at 30 days. |
| Average Number of Ports | Ability to adequately retract the uterus, adnexal organs, and peri uterine tissue to achieve an effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if an additional port that is typically used for retraction and exposure of target tissues can be eliminated. | During index procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Females
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Borja Arriaran | Peñalolén | Santiago Metropolitan | Chile | |||
| Hospital Santiago Oriente "Dr. Luis Tisné Brousse" |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Peñalolén |
| Santiago Metropolitan |
| Chile |