Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearifyâ„¢ Visualization System (D-HELP) during laparoscopic surgery.
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearifyâ„¢ Visualization System (D-HELP) during laparoscopic surgery. The study will be randomized across two groups, one group will evaluate laparoscopic lens cleaning with D-HELP during laparoscopic surgery and the second group will evaluate laparoscopic lens cleaning using the FloShield Air System during laparoscopic surgery. Each surgery will be captured on video. Study parameters will be evaluated through review of each video by an independent evaluator.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FloShield | Other | FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery |
|
| Clearify | Other | Clearify Visualization System used during laparoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic surgery | Procedure | gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery; |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of Laparoscope removals during surgery | The performance evaluations of the FloShield Air System will be based the difference between the cohorts on the number of scope removals per surgery. | 0.5hr - 6hr |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wayne Poll, MD | President and CEO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Miami Hospital | South Miami | Florida | 33143 | United States | ||
| Centennial Hills Medical Center |
Not provided
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FloShield Defogging and Cleaning System | Device | Sterile, single-use in vivo device to clean and defog the laparoscope camera lens |
|
|
| Clearify Defogging and Cleaning System | Device | Single-use, ex vivo device to clean and defog the laparoscope camera lens |
|
| Las Vegas |
| Nevada |
| 89149 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45206 | United States |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |