Iron Deficiency AnemiaNCT04782986
Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding
A study testing Pan-intestinal capsule endoscopy in people with Iron Deficiency Anemia and GastroIntestinal Bleeding, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
Trial summary
The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy. Read more about this study
- Who is it for?
- Ages 8 to 100 years
- Conditions the study is for
- Iron Deficiency Anemia, GastroIntestinal Bleeding
- What is being tested?
- Pan-intestinal capsule endoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Jun 2020to 31 Jan 2023
- Phase
- Interventional
- 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 8 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb <12.0 g/dL in female gender or <13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD)
Who cannot join
- Lack of informed consent
- Suspected lesions at index EGD that could justify the anemia or digestive bleeding
- Known history of gastroparesis or bowel dysmotility
- Known or suspected intestinal stricture
- Female patients with potential gynaecological source of bleeding causative of the clinical condition
- Patients with severe malnutrition
Show all 9Show fewer
- Patients unable to walk at least for short periods and/or with neurological and/or psychiatric condition potentially favouring protocol deviations
- Allergy or contra-indications to any of the drugs or products used in the study
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Gastroenterology Department, Hospital da Senhora da Oliveira
Guimarães, 4835-044
About this study
Official title: Pan-intestinal Capsule Endoscopy Versus Conventional Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding: a Prospective Cohort Study
The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy.
Read the detailed description
Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the colon in a single non-invasive examination, opens new perspectives for the management of those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic. The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may allow, in a safe and well tolerated manner, to identify which patients would benefit of further interventions, such as colonoscopy or invasive enteroscopy, guided by findings pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal capsule endoscopy is superior to the current standard strategy of conventional colonoscopy after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding diagnostic yield, safety and tolerability.
- Conditions
- Iron Deficiency Anemia, GastroIntestinal Bleeding
- Being tested
- Pan-intestinal capsule endoscopy
- Keywords
- iron deficiency anemia, gastrointestinal bleeding, pan-intestinal capsule endoscopy
- Medical subject headings
- Anemia, Iron-Deficiency, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan-intestinal capsule endoscopyDiagnostic test
Also called Conventional colonoscopy
Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation
| Study group | Role | What they receive |
|---|---|---|
| Pan-intestinal capsule endoscopy | Experimental | PillCam Crohn's capsule protocol Receives: Diagnostic Test: Pan-intestinal capsule endoscopy |
| Conventional colonoscopy | Active comparator | Same-day colonoscopy under propofol sedation Receives: Diagnostic Test: Pan-intestinal capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon
Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding
Measured: 2 weeks
Secondary outcomes (2)
Safety: number of participants with any procedure-related adverse events
Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications
Measured: 2 weeks
Patient's preference: number of participants preferring capsule endoscopy or colonoscopy
Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start19 Jun 2020
- Primary completion20 Sep 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Prospective, single-blinded, single center cohort study. All patients will undergo pan-intestinal capsule endoscopy followed by conventional colonoscopy with deep sedation in the same day, with no need for further bowel preparation.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPE
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Bruno Rosa, Unidade Local de Saúde do Alto Ave, EPE
- Investigators
- Bruno Rosa, MD, Principal investigator, Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782986
- Sponsor's protocol ID
- ERP-2020-12296
- Status last verified
- Sep 2023
- First submitted
- 20 Feb 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Souto M, Goncalves J, Silva VM, Rosa B, Cotter J. Concordance Between Pan-Intestinal Capsule Endoscopy and Colonoscopy for the Detection and Characterization of Colonic Lesions: Post Hoc Analysis on the Impact of Colonic Transit Time. J Gastroenterol Hepatol. 2026 Aug;41(8):2419-2426. doi: 10.1111/jgh.70505. Epub 2026 Jun 21.
PubMed 42323957
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-intestinal Capsule Endoscopy Versus Conventional Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04782986
- Acronym / sponsor ID
- ERP-2020-12296
- Conditions
- Iron Deficiency Anemia, GastroIntestinal Bleeding
- Keywords
- iron deficiency anemia, gastrointestinal bleeding, pan-intestinal capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPEUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 4 Mar 2021 (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.
The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy.
Detailed description
Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the colon in a single non-invasive examination, opens new perspectives for the management of those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic. The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may allow, in a safe and well tolerated manner, to identify which patients would benefit of further interventions, such as colonoscopy or invasive enteroscopy, guided by findings pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal capsule endoscopy is superior to the current standard strategy of conventional colonoscopy after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding diagnostic yield, safety and tolerability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, single-blinded, single center cohort study. All patients will undergo pan-intestinal capsule endoscopy followed by conventional colonoscopy with deep sedation in the same day, with no need for further bowel preparation.
| Arm | Type | Receives |
|---|---|---|
| Pan-intestinal capsule endoscopy | Experimental | Diagnostic Test: Pan-intestinal capsule endoscopyPillCam Crohn's capsule protocol |
| Conventional colonoscopy | Active comparator | Diagnostic Test: Pan-intestinal capsule endoscopySame-day colonoscopy under propofol sedation |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb <12.0 g/dL in female gender or <13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD)
Key exclusion criteria (9 listed)
- Lack of informed consent
- Suspected lesions at index EGD that could justify the anemia or digestive bleeding
- Known history of gastroparesis or bowel dysmotility
- Known or suspected intestinal stricture
- Female patients with potential gynaecological source of bleeding causative of the clinical condition
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 |
|---|---|---|
| Pan-intestinal capsule endoscopyAlso: Conventional colonoscopyPatients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation | Diagnostic test | Conventional colonoscopy, Pan-intestinal capsule endoscopy |
Primary outcome
Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon
Time frame: 2 weeks
Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding
2 secondary outcomes
Safety: number of participants with any procedure-related adverse events
Time frame: 2 weeks
Patient's preference: number of participants preferring capsule endoscopy or colonoscopy
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 42323957Souto M, Goncalves J, Silva VM, Rosa B, Cotter J. Concordance Between Pan-Intestinal Capsule Endoscopy and Colonoscopy for the Detection and Characterization of Colonic Lesions: Post Hoc Analysis on the Impact of Colonic Transit Time. J Gastroenterol Hepatol. 2026 Aug;41(8):2419-2426. doi: 10.1111/jgh.70505. Epub 2026 Jun 21.
- Individual participant dataSharing planned: No
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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.
Bruno Rosa, MD principal investigator
Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pan-intestinal capsule endoscopy in people with Iron Deficiency Anemia and GastroIntestinal Bleeding, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
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 9 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: finished, as of the sponsor's last update on 22 Sep 2023. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782986, which also lists 1 linked publication.
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 22 Sep 2023.