Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy

This is an interventional diagnostic trial for Intestinal Abnormalities focused on measuring intestinal abnormalities Read More

Inclusion criteria - Patients

• Patient's age is 16-80 years, inclusive.

• One of the following SB manometry procedures:

  • Underwent SB manometry within five years if results were abnormal
  • Underwent SB manometry within 1 year if results were normal
  • Scheduled for SB manometry within six months of enrollment date

• Patient was indicated for small bowel manometry based on one or both of the following symptoms:

  • Pseudo obstruction of the small bowel: symptoms resembling mechanical small bowel obstruction without evidence of luminal compromise of the gut. Mechanical occlusion is ruled-out by endoscopic and / or radiological studies following the criteria of the attending physician.

Patients may have any of the following:

• recurrent acute episodes (at least two) with air fluid levels (as evidenced at least once by abdominal X-ray), or
• chronic symptoms with small bowel dilation resembling a partial mechanical obstruction.

Patients will be tested during period of (non-acute) remission. - Chronic severe GI symptoms with inability to maintain normal body weight: abdominal symptoms (such as nausea, abdominal distension, discomfort or pain) produce inability to maintain a normal body weight as defined by unintentional weight loss of at least 10% of original body weight before onset of symptoms or a BMI < 18.5, while on a normal diet (without oral dietary supplements, enteral or parenteral feeding).

These should be chronic symptoms lasting at least 6 months.

- Patient or legal guardian agrees to sign consent form

Exclusion criteria - Patients

• Acute exacerbation of chronic obstructive symptoms.
• Mechanical obstruction of any kind such as definite long stricture seen on radiological exam.
• Suspected GI stricture, followed by Agile® study that could not prove patency of the GI tract.
• Known history of small bowel organic disease such as Crohn's Disease or Celiac.
• Patient suffers from any condition, such as swallowing problems or having an implanted cardiac pacemaker or defibrillator which precludes compliance with study and/or device instructions.
• Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding the CE exam.
• Patient has undergone gastrectomy (segmental small bowel resection over 30%).
• During the period between small bowel manometry and Capsule endoscopy, the patient has undergone any abdominal surgical procedures other than appendectomy, cholecystectomy, abdominal wall hernia repair or catheter placing for enteral feeding.
• Manometry was performed before any other allowed GI procedure.
• Patient is pregnant.
• Known abuse of alcohol or illicit substances.
• Patient presently presenting with an acute life threatening condition.
• Participating in another clinical study within 30 days.

Inclusion criteria - Healthy Volunteers

• Volunteer's age is 16-80 years, inclusive.
• Volunteer or legal guardian agrees to sign consent form. 6.5.2 Exclusion criteria - Healthy Volunteers
• Known diabetes mellitus
• Recurrent Gastrointestinal symptoms
• Volunteer suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
• Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
• More than one answer above 'mild' on the healthy volunteer symptoms questionnaire (Appendix C).
• Female volunteer is pregnant
• Known abuse of alcohol or illicit substances.
• Participating in another clinical study within 30 days