GastroIntestinal BleedingNCT05949268
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
An observational study of GastroIntestinal Bleeding, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- GastroIntestinal Bleeding
- What is being tested?
- Small bowel capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,300 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 15 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.
Who may be able to join
- suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy
- informed consent
Who cannot join
- contraindications for small bowel capsule endoscopy (e.g. stenosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, 79106
Michael Schultheiss, MD, 49761270-34010, michael.schultheiss@uniklinik-freiburg.de
Dominik Bettinger, MD
About this study
Official title: Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum
Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.
Read the detailed description
Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to > 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.
- Conditions
- GastroIntestinal Bleeding
- Being tested
- Small bowel capsule endoscopy
- Keywords
- Small bowel capsule endoscopy, gastrointestinal bleeding, anticaogulation
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small bowel capsule endoscopyDevice
Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy | Gastrointestinal bleeding in the small bowel. Receives: Device: Small bowel capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of small bowel bleeding detected during small bowel capsule endoscopy
Detection of bleeding during small bowel capsule endoscopy
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Prevalence of vascular lesions as source of bleeding
Detection of vascular lesions angiodysplasia) as source of bleeding
Measured: Through study completion, an average of 1 year
Prevalence of inflammatory lesions as source of bleeding
Detection of inflammatory lesions as source of bleeding
Measured: Through study completion, an average of 1 year
Prevalence of tumor lesions as source of bleeding
Detection of tumor lesions as source of bleeding
Measured: Through study completion, an average of 1 year
Complications of small bowel capsule endoscopy
Complications of small bowel capsule endoscopy
Measured: Through study completion, an average of 1 year
Technical success of small bowel capsule endoscopy
Technical success is defined as arrival of the capsule in the cecum
Measured: Through study completion, an average of 1 year
Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
Time between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
Measured: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Jul 2028 (estimated)
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 GastroIntestinal BleedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dominik Bettinger, University Hospital Freiburg
- Investigators
- Michael Schultheiss, MD, Principal investigator, University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949268
- Sponsor's protocol ID
- Capsule endoscopy_FR
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are shared on reasonable request to the Principal Investigator.
Publications
Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.
PubMed 29539652
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum
- ClinicalTrials.gov ID
- NCT05949268
- Acronym / sponsor ID
- Capsule endoscopy_FR
- Conditions
- GastroIntestinal Bleeding
- Keywords
- Small bowel capsule endoscopy, gastrointestinal bleeding, anticaogulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 18 Jul 2023 (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.
Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.
Detailed description
Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to > 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy | – | Device: Small bowel capsule endoscopyGastrointestinal bleeding in the small bowel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.
Key inclusion criteria (2 listed)
- suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy
- informed consent
Key exclusion criteria (1 listed)
- contraindications for small bowel capsule endoscopy (e.g. stenosis)
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 |
|---|---|---|
| Small bowel capsule endoscopyPatients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy. | Device | Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy |
Primary outcome
Prevalence of small bowel bleeding detected during small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Detection of bleeding during small bowel capsule endoscopy
6 secondary outcomes
Prevalence of vascular lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Prevalence of inflammatory lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Prevalence of tumor lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Complications of small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Technical success of small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
Time frame: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 29539652Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.
- Individual participant dataSharing planned: No. IPD are shared on reasonable request to the Principal Investigator.
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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.
Michael Schultheiss, MD principal investigator
University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany
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 GastroIntestinal Bleeding, run by University Hospital Freiburg at 1 site in Germany.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Schultheiss, MD (+49761/270-34010, michael.schultheiss@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of small bowel bleeding detected during small bowel capsule endoscopy (time frame: Through study completion, an average of 1 year). 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 NCT05949268, 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 1 May 2026.