Trials / Completed
CompletedNCT00832767
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 202 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SILS™ port laparoscopic cholecystectomy | This interventional arm will have a single incision laparoscopic cholecystectomy procedure. |
| PROCEDURE | Four Port Laparoscopic Cholecystectomy | This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2011-09-01
- Completion
- 2012-01-01
- First posted
- 2009-01-30
- Last updated
- 2017-12-18
- Results posted
- 2017-12-18
Locations
10 sites across 3 countries: United States, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT00832767. Inclusion in this directory is not an endorsement.