Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | September 2015 |
Post Market Study: Use of the Reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator and the Robotic FloShield System During Robot-assisted Laparoscopic Single-Site Surgery. A Multicenter Historical Control Comparison
This study evaluates the use of the FloShield System with the FloShield 10mm reusable
Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study
will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci®
Robotic Surgical System during single-site laparoscopic surgery.
Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study
will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci®
Robotic Surgical System during single-site laparoscopic surgery.
Inclusion Criteria:
- Male or female, 18 years or older
- Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign
hysterectomy or salpingo-oophorectomy under the care of the study investigator
- Suitable candidate for surgery
- Is able to read and understand the informed consent form and has voluntarily provided
written informed consent
Exclusion Criteria:
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at
the discretion of the investigator)
- Subjects with known allergy (hypersensitivity) to Docusate Sodium
- Use of Surgiquest AirSeal during the laparoscopic single-site surgery
- Use of humidified insufflation
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