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NCT06219395 Clinical Trial

Capsule Endoscopy in Iron Deficiency Anaemia

Iron Deficiency Anemia Clinical Trial

— WCE-IDA  

Official title:
Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06219395
Other study ID # 281233
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date September 30, 2025

Study information
Verified date January 2024
Source Vastra Gotaland Region
Contact Thomas de Lange, PhD
Phone +46702794054
Email thomas.de.lange@vgregion.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)

Description:

IDA is common and 90-95% of cases are caused by bleeding from ulcers, tumours or vascular malformations in the oesophagus, stomach, duodenum, small intestine or the large bowel.Bleeding from more than one localisation is common. International guidelines recommend bidirectional endoscopy(gastro- and colonoscopy) to detect and treat the source of bleeding. Our hypothesis is that WCE is non-inferior to the combination of gastroscopy and colonoscopy in locating GI-bleeding and that complete examinations will be achieved in ≥90% of the examinations.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date September 30, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Referred to flexible endoscopy for a verified Iron Deficiency Anaemia Exclusion Criteria: - Unwillingness to participate - Not able to provide informed consent - Not understanding the instructions - Severe cardio-vascular disease New York Heart Association III-IV - Symptoms of bowel obstruction/previous bowel obstruction - Bowel surgery except for end to end anastomosis in the colon - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopy
Patients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic yield Mucosal lesions detected 90 minutes
Secondary Small bowel lesions Number of lesions detected in the small bowel 90 minutes
Secondary Complete examination Proportion of complete examinations 90 minutes
Secondary Bowel preparation Proportion of satisfactory bowel preparation 90 minute
Secondary Adequate examinations Proportion of adequate examinations defined as both satisfactory bowel preparation and complete examination 90 minutes
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