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Covidien Triad monopolar generator · 1 trial · 3 indications
Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.
| Arm | Type | Description |
|---|---|---|
| Coag mode 30 Watts Power | NO_INTERVENTION | Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care. |
| Covidien Triad monopolar generator | EXPERIMENTAL | Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode. |
| Name | Type | Description |
|---|---|---|
| Covidien Triad monopolar generator | DEVICE | Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy. |
Inclusion Criteria: * Age 18 years and older planned to undergo elective laparoscopic cholecystectomy Exclusion Criteria: * Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
The Covidien Triad monopolar generator is a medical device used in surgical procedures to prevent intraoperative complications, specifically thermal injury at port site skin during laparoscopic cholecystectomy. It is being studied in a Phase 3 clinical trial for this purpose.
The Covidien Triad monopolar generator is developed by Medtronic plc, which trades under the ticker MDT. The device is being evaluated in a clinical trial for its role in reducing intraoperative complications.
The Covidien Triad monopolar generator is in Phase 3 clinical development. It is an investigational device being studied for the prevention of thermal injury during laparoscopic cholecystectomy, and it is not yet approved for this use.
The Covidien Triad monopolar generator is being studied in one completed Phase 3 trial, NCT01664806, titled 'Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin'. The trial enrolled 40 participants in the United States.
The Covidien Triad monopolar generator is an investigational device in Phase 3 clinical development. It has not been approved by the FDA for the prevention of intraoperative complications, as it is still undergoing clinical evaluation.