Protocol Defined Important Medical Findings Sample Clauses

Protocol Defined Important Medical Findings. Requiring Real Time Reporting pH Pill Sub-Study: Specific procedures to following in the event of a retained WMC. If a subject has not passed the capsule 14 days after ingestion and the pH profile as well as pressure profile as reviewed by the Children’s Hospital of Buffalo upon receiving the radiofrequency detector does not indicate that it has passed into the colon, abdominal x-rays (flat and upright) will be obtained. If the capsule is identified by x-ray but the subject is not having pain and does not have evidence of air-fluid levels, polyethylene glycol (17 grams in 8 ounces of liquid) will be prescribed, to be taken orally three times a day until the capsule has passed into the colon or has been evacuated. Consultation with a gastroenterologist for possible endoscopy and manual removal will be scheduled if the subject has severe abdominal pain secondary to capsule retention, with air-fluid level on abdominal x-rays. Study sites will follow the SAE reporting requirements as specified in section 10.2.1 for any subject experiencing capsule retention 14 days after ingestion.
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