Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT06212206
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Ability to provide written, informed consent to undergo both capsule endoscopy (un-sedated) and conventional OGD
* Willing and able to complete study follow-up requirements
* Patient has appropriate indications for upper endoscopy including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain
Exclusion Criteria:
All patients who meet any of the following criteria should not be enrolled into the study:
* Coagulopathy with INR \> 1.5, thrombocytopenia with platelet counts \< 50,000
* Active bleeding
* Need for therapeutic procedures during endoscopy
* Lactation
* Dysphagia, or other swallowing disorders
* Known esophageal diverticulum or stricture
* Swallowing disorder
* Known luminal, gastrointestinal strictures
* Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent Computed tomography enterography (CTE) or Magnetic resonance enterography (MRE), MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule
* History of esophageal, gastric surgery or intestinal surgery
* Esophageal or GI motility disorder
* Known or suspected gastrointestinal obstruction, significant intestinal strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
* Current participation in another investigational drug or device treatment study
* Pregnant or wishes to become pregnant during the study follow-up period
* Patient with implanted medical device that would be potentially affected radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators)
* Severe psychiatric, neurological, cardio-vascular, or renal disorders
* History of allergy or intolerance to materials used to make the PillBot
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06212206
Study Brief:
Protocol Section:
NCT06212206