Iron Deficiency AnemiaWCE-IDANCT06219395
Capsule Endoscopy in Iron Deficiency Anaemia
An observational study of Iron Deficiency Anemia and Bowel Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Iron Deficiency Anemia, Bowel Cancer
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Persons with Iron Deficiency Anaemia referred for endoscopic diagnostic work-up
Who may be able to join
- Referred to flexible endoscopy for a verified Iron Deficiency Anaemia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nikolaos Papachrysos, PhD contact
About this study
Official title: Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia
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)
Read the 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.
- Conditions
- Iron Deficiency Anemia, Bowel Cancer
- Being tested
- Endoscopy
- Medical subject headings
- Anemia, Iron-Deficiency, Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Patients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency anaemia | Persons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Mucosal lesions detected
Measured: 90 minutes
Secondary outcomes (4)
Small bowel lesions
Number of lesions detected in the small bowel
Measured: 90 minutes
Complete examination
Proportion of complete examinations
Measured: 90 minutes
Bowel preparation
Proportion of satisfactory bowel preparation
Measured: 90 minute
Adequate examinations
Proportion of adequate examinations defined as both satisfactory bowel preparation and complete examination
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Thomas de Lange, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219395
- Sponsor's protocol ID
- 281233
- Acronym
- WCE-IDA
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia
- ClinicalTrials.gov ID
- NCT06219395
- Acronym / sponsor ID
- WCE-IDA / 281233
- Conditions
- Iron Deficiency Anemia, Bowel Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency anaemia | – | Procedure: EndoscopyPersons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Persons with Iron Deficiency Anaemia referred for endoscopic diagnostic work-up
Key inclusion criteria (1 listed)
- Referred to flexible endoscopy for a verified Iron Deficiency Anaemia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopyPatients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE | Procedure or surgery | Iron deficiency anaemia |
Primary outcome
Diagnostic yield
Time frame: 90 minutes
Mucosal lesions detected
4 secondary outcomes
Small bowel lesions
Time frame: 90 minutes
Complete examination
Time frame: 90 minutes
Bowel preparation
Time frame: 90 minute
Adequate examinations
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Papachrysos, PhD contact
Thomas de Lange, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Bowel Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas de Lange, PhD (+46702794054, thomas.de.lange@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.