Ascorbic acid; Sodium ascorbate; Potassium chloride; Sodium chloride; Sodium sulfate anhydrous; Macrogol 3350 for Comparison of diagnostic tools

Inclusion criteria

• {"criterion_text":"- Patients aged 18 years or older who are indicated to undergo a small bowel study using capsule endoscopy and whose indication is included in standard clinical practice"}
• {"criterion_text":"- They will provide signed informed consent for performing capsule endoscopy."}
• {"criterion_text":"- Provide signed and dated informed consent for entry into the clinical trial"}

Exclusion criteria

• {"criterion_text":"- Suspected or diagnosed gastrointestinal obstruction/perforation."}
• {"criterion_text":"- Known small bowel strictures"}
• {"criterion_text":"- Patients with severe gastroparesis"}
• {"criterion_text":"- In case of previous Patency® capsule production: Deformed retention or expulsion of the capsule."}
• {"criterion_text":"- pregnant"}
• {"criterion_text":"- Patients with severe liver, cardiovascular or kidney disease that contraindicates preparation with polyethylene glycol (Movipep®)."}
• {"criterion_text":"- Patients who present or have presented any adverse reaction or allergy to polyethylene glycol (Moviprep ®) or simethicone."}

Primary endpoints

• {"endpoint_text":"- Degree of small bowel cleansing using an accepted cleansing scale.","definition_or_measurement_approach":"Using an accepted cleansing scale."}

Secondary endpoints

• {"endpoint_text":"- Diagnostic yield of capsule endoscopy defined as: finding of clinically significant lesions.","definition_or_measurement_approach":"Defined as finding of clinically significant lesions (diagnostic yield)."}
• {"endpoint_text":"- Gastric transit time (GTT): Defined as the time elapsed from the first gastric image to the first duodenal image. This value will be expressed in minutes.","definition_or_measurement_approach":"Time elapsed from the first gastric image to the first duodenal image; expressed in minutes."}
• {"endpoint_text":"- Small bowel transit time (STT): This is defined as the time elapsed from the first duodenal image to the first cecal image. When the study does not reach the cecum, the last image of the study will be considered as the first cecal image and it will be indicated that the cecum has not been reached. This value will be expressed in minutes.","definition_or_measurement_approach":"Time elapsed from the first duodenal image to the first cecal image; if cecum not reached the last image is considered first cecal image; expressed in minutes."}
• {"endpoint_text":"- Tolerability of the preparation: Expresses the degree of acceptance or non-acceptance by the patient of the preparation. For this purpose, a questionnaire will be used, which is not validated, and will be completed at the time the capsule is administered.","definition_or_measurement_approach":"Assessed by a non-validated questionnaire completed at time of capsule administration to express degree of acceptance/tolerability."}
• {"endpoint_text":"- Percentage of complete studies: A study is considered complete when it has reached the blind spot during the recording time.","definition_or_measurement_approach":"Proportion of studies reaching the cecum ('blind spot') during recording time."}
• {"endpoint_text":"- Other variables: Demographic variables: age, gender, personal history. Reason for requesting capsule endoscopy and diagnosis found. Previous treatment with antiplatelet agents, anticoagulants, non-steroidal anti-inflammatory drugs and/or prokinetics.","definition_or_measurement_approach":"Collection of demographic and clinical variables including medication history and reason for capsule endoscopy."}

Spain

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

5

Number Of Sites

2

Number Of Participants

156

Primary sponsor

Full Name

Hospital Universitario La Paz

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain