Viewing Study NCT06219395


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Ignite Modification Date: 2025-12-25 @ 3:16 PM
Study NCT ID: NCT06219395
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-01-23
First Post: 2024-01-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Capsule Endoscopy in Iron Deficiency Anaemia
Sponsor: Vastra Gotaland Region
Organization:

Study Overview

Official Title: Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WCE-IDA
Brief 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)
Detailed 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: