An Open-Label Preference Evaluation of BLI800

BLI800-491

The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

2019-09-24

2019-11-21

2019-11-21

Completed

Early phase I

40

Primary Inclusion Criteria: * Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication * 18 to 85 years of age (inclusive) * If female, and of child-bearing potential, is using an acceptable form of birth control * Negative urine pregnancy test at screening, if applicable * In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Primary Exclusion Criteria: * Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon * Subjects with ongoing severe, acute inflammatory bowel disease * Subjects who had previous significant gastrointestinal surgeries * Subjects with known severe renal, hepatic or cardiac insufficiency * Subjects undergoing insulin therapy for any indication * Subjects with impaired consciousness that predisposes them to pulmonary aspiration * Subjects undergoing colonoscopy for foreign body removal and/or decompression

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-10-23