Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
Colonoscopy, Colonic Polyps

About this trial
This is an interventional treatment trial for Colonoscopy focused on measuring Colonoscopy, Sedation, AQUAVAN, (fospropofol disodium), Endoscopic sedation, Endoscopic outcomes, Endoscopy
Eligibility Criteria
- Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites will be randomized into this study. - Study Country Location: United States - Study Population: Male and female patients aged 18 years and older and undergoing elective colonoscopy will be enrolled in the study. Inclusion Criteria: Patient provides signed/dated informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study Patient must be at least 18 years of age at the time of screening If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and has been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and pre-dose Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4 Exclusion Criteria: Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines Patient has a Mallampati classification score of 4; OR a Mallampati classification score of 3 AND a thyromental distance <= 4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator Patient has an abnormal, clinically significant 12-lead ECG finding at predosing period Day 0 Patient has participated in an investigational drug study within 1 month prior to study start Patient is unwilling to adhere to pre- and post-procedural instructions Patient for whom the use of fentanyl is contraindicated Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated
Sites / Locations
- Clinical Research Associates
- Arizona Research Center
- Atlanta Gastroenterology Associates
- Rockford Gastroenterology Associates Ltd.
- Welborn Clinic
- Gulf Coast Research Associates, Inc.
- Gastroenterology Clinic
- Chevy Chase Clinical Research
- Endoscopic Microsurgery Associates, PA
- Gastrointestinal Associates, PA
- Winthrop-University Hospital
- Research Associates of New York
- Asheville Gastroenterology Associates/The Endoscopy Center
- Oklahoma Gastroenterology Associates
- Memphis Gastroenterology Group, PC
- Gastrointestinal Institute
- St. Thomas Medical Group, P.C.
- Alamo Research Center
- Spokane Digestive Diseases Center
- Wisconsin Center for Advance Research