NCT06219395

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 12, 2024

Last Update Submit

January 12, 2024

Conditions

Iron Deficiency AnemiaBowel Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    Mucosal lesions detected

    90 minutes

Secondary Outcomes (4)

  • Small bowel lesions

    90 minutes

  • Complete examination

    90 minutes

  • Bowel preparation

    90 minute

  • Adequate examinations

    90 minutes

Study Arms (1)

Iron deficiency anaemia

Persons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy

Procedure: Endoscopy

Interventions

EndoscopyPROCEDURE

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

Iron deficiency anaemia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with Iron Deficiency Anaemia referred for endoscopic diagnostic work-up

You may qualify if:

  • Referred to flexible endoscopy for a verified Iron Deficiency Anaemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIntestinal Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Thomas de Lange, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas de Lange, PhD

CONTACT

+46702794054thomas.de.lange@vgregion.se

Nikolaos Papachrysos, PhD

CONTACT

nikolaos.papachrysos@vgregion.se

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

March 1, 2024

Primary Completion

February 28, 2025

Study Completion

September 30, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

SE(1)