- Poor general health, presence of a specific condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or placement of the BIB, or may interfere significantly with the subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history within the last 5 years)