None listed
Conditions
Interventions
This multi center study will assess the ability of the GIVEN Patency System to verify the patency of the GI tract in patients with known strictures in the small bowel. The overall plan for all patients consists of the following elements:
Patient is assessed for his eligibility to participate in the study.
Patient ingests a GIVEN Patency Capsule.
Patient is followed using the GIVEN Patency Scanner until the excretion of the capsule and/or its components.
Patients will undergo fluoroscopy 32-38 h
This multi center study will assess the ability of the GIVEN Patency System to verify the patency of the GI tract in patients with known strictures in the small bowel. The overall plan for all patients consists of the following elements: Patient is assessed for his eligibility to participate in the study. Patient ingests a GIVEN Patency Capsule. Patient is followed using the GIVEN Patency Scanner until the excretion of the capsule and/or its components. Patients will undergo fluoroscopy 32-38 hours after ingestion. Patients will undergo fluoroscopy (as applicable) 68-72 hours after ingestion Patients will undergo fluoroscopy (as applicable) 94-100 hours after ingestion Patient with patent GI tract will undergo PillCam SB Capsule Endoscopy to further assess the patient's condition and evaluate the correlation between the results of GIVEN Patency Capsule passage and the PillCam SB Capsule findings
Sponsors
Given Imaging Ltd., New Industrial Park, Yoqneam, Israel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is known to suffer from intestinal stricture based on an X-ray test, and/or SBFT and/or abdominal CT scan performed within the last 3 months [these tests will be repeated only if there are recent changes in the patients clinical conditions during this period. 2. Patient is able and agrees to sign the Informed Consent Form.
Exclusion criteria
1. Patient suffers from swallowing disorders 2. Patient has less than 2 bowel movements per week (to be confirmed by bowel movement log)3. Female patient is pregnant (women of childbearing potential will have to perform a urine pregnancy test before the ingestion).4. Patient has any condition, which precludes compliance with study and/or device instructions.5.Patient has cardiac pacemakers or other electro medical implant6.Patient suffers from life threatening conditions7.Patient is currently participating in another clinical study.
Outcome results
None listed