GI-bleedingPhase 2/3NCT01584869
Emergency Capsule Endoscopy in Severe GI-bleeding
A Phase 2/3 study testing capsule endoscopy in people with GI-bleeding, run by Technical University of Munich at 1 site in Germany.
Trial summary
Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI-bleeding
- What is being tested?
- capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Mar 2014
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with signs of severe GI-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or MAP < 80 mmHg or HR > 110) and/or drop of hemoglobin > 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells
Who cannot join
- missing consent form, pregnancy, origin of bleeding found in upper GI-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, Angiodysplasia (with signs of bleeding), refluxesophagitis LA C or D) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.
- Conditions
- GI-bleeding
- Being tested
- capsule endoscopy
- Keywords
- GI-bleeding, capsule endoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| capsule endoscopy | Experimental | Not described Receives: Device: capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.
Measured: after complete recruitment
Secondary outcomes (2)
frequency of mid-GI-bleeding in all patients
diagnostic yield
Measured: after complete recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2014
- Study completionMar 2014
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 GI-bleedingStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584869
- Sponsor's protocol ID
- 23042012
- Status last verified
- Jan 2015
- First submitted
- 23 Apr 2012
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schlag C, Menzel C, Nennstiel S, Neu B, Phillip V, Schuster T, Schmid RM, von Delius S. Emergency video capsule endoscopy in patients with acute severe GI bleeding and negative upper endoscopy results. Gastrointest Endosc. 2015 Apr;81(4):889-95. doi: 10.1016/j.gie.2014.09.035.
PubMed 25432532
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Capsule Endoscopy in Severe GI-bleeding
- ClinicalTrials.gov ID
- NCT01584869
- Acronym / sponsor ID
- 23042012
- Conditions
- GI-bleeding
- Keywords
- GI-bleeding, capsule endoscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Apr 2012 (estimated)
- 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.
Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsule endoscopy | Experimental | Device: capsule endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with signs of severe GI-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or MAP < 80 mmHg or HR > 110) and/or drop of hemoglobin > 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells
Key exclusion criteria (1 listed)
- missing consent form, pregnancy, origin of bleeding found in upper GI-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, Angiodysplasia (with signs of bleeding), refluxesophagitis LA C or D) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease
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 |
|---|---|---|
| capsule endoscopy | Device | capsule endoscopy |
Primary outcome
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.
Time frame: after complete recruitment
2 secondary outcomes
frequency of mid-GI-bleeding in all patients
diagnostic yield
Time frame: after complete recruitment
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 29 Jan 2015.
- Derived from this study: PubMed 25432532Schlag C, Menzel C, Nennstiel S, Neu B, Phillip V, Schuster T, Schmid RM, von Delius S. Emergency video capsule endoscopy in patients with acute severe GI bleeding and negative upper endoscopy results. Gastrointest Endosc. 2015 Apr;81(4):889-95. doi: 10.1016/j.gie.2014.09.035.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing capsule endoscopy in people with GI-bleeding, run by Technical University of Munich 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 1 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: finished, as of the sponsor's last update on 29 Jan 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures. (time frame: after complete recruitment). 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 NCT01584869, 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 29 Jan 2015.