Status:
COMPLETED
Role of AI in CE for the Identification of SB Lesions in Patients With Small Intestinal Bleeding.
Lead Sponsor:
Fondazione Poliambulanza Istituto Ospedaliero
Collaborating Sponsors:
Humanitas Hospital, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Iron Deficiency Anemia
Obscure Gastrointestinal Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Capsule Endoscopy (CE) is a safe, patient friendly and easy procedure performed for the evaluation of gastrointestinal tract unable to be explored via conventional endoscopy. The most common indicatio...
Detailed Description
This is a multicenter, multinational, blinded prospective trial, involving a consecutive series of patients recruited by 12 European centers based on the indication of OGIB: * after negative upper an...
Eligibility Criteria
Inclusion
- indication of OGIB:1)after negative upper and lower endoscopy; 2)France: after negative pregnancy test; 3)Hb cut-off male: \<13, female: \<12
Exclusion
- Age \< 18 years old
- Known or suspected intestinal obstruction
- Non-steroidal anti-inflammatory drugs (twice weekly or more) during the 4 weeks preceding enrollment
- Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
- Patient with known gastrointestinal motility disorders
- Subjects with known or suspected delayed gastric emptying
- Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
- Patient has any allergy or other known contraindication or intolerance to the medications used in the study
- Patient has any condition, which precludes compliance with study and/or device instructions
- Patient with any contraindication to take the bowel preparation product
- Women who are either pregnant or nursing at the time of screening, or are of child- bearing potential and do not practice medically acceptable methods of contraception
- Concurrent participation in another clinical trial using any investigational drug or device
- Patient suffers from a life-threatening condition
- Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters
- Patients with pace-maker or implantable cardioverter
- Patient did not sign informed consent
- Endoscopic placement of the capsule
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04821349
Start Date
February 16 2021
End Date
October 1 2022
Last Update
February 21 2024
Active Locations (1)
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1
Fondazione Poliambulanza
Brescia, Italy, 25124