Phase
Condition
Colon Polyps
Colon Cancer Screening
Treatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient provided a signed/dated Informed Consent and HIPAA authorization afterreceiving a full explanation of the extent and nature of the study;
Patient, if female, were surgically sterile, postmenopausal or non-pregnant and nonlactating using an acceptable method of birth control for at least 1 month prior todosing, with a negative urine pregnancy test result at screening and predose periods;and
Patient met American Society of Anesthesiologists (ASA) Physical Status ClassificationSystem of I to III.
Exclusion
Exclusion Criteria:
Patient had a history of allergic reaction or hypersensitivity to any anestheticagent, narcotic, or benzodiazepine;
Patient did not meet nils per os (NPO) status per ASA Guideline or institution'sguideline.
Patient had condition(s) that, in the opinion of the Investigator, could interferewith appropriate airway management;
Patient participated in an investigational drug study within 1 month prior to studystart;
Patient had a history of mental or visual impairment that would not permit successfulmeasurement of cognitive evaluations;
Patient was unwilling to adhere to pre- and postprocedural instructions; or
Patient for whom the use of fentanyl or midazolam was contraindicated.