MelenaFIRMNCT04019067
Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
A study testing MCE first in people with Melena, run by Changhai Hospital.
Trial summary
MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melena
- What is being tested?
- MCE first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Presenting to the outpatient department or emergency department with melena (without hematemesis) within the previous 48 hours
- Hemodynamically stable (blood pressure > 100/60 mmHg and heart rate < 100 bpm) at presentation
- No endoscopy performed after the new onset of melena
Who cannot join
- Presenting with hematochezia and/or hematemesis within the previous 48 hours of presentation
- Hemodynamically stable after initial volume resuscitation
- Drop of hemoglobin level ≥ 2 g/dL/day, and/or need of transfusion ≥ 2 units of packed red blood cells per day
- Contraindications of CE (e.g. dysphagia, Zenker's diverticulum, esophageal stricture, known or suspected gastric or small bowel obstruction or perforation, gastroparesis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation, etc.)
- Presence of internal cardiac defibrillator (ICD), pacemaker and/or other implanted electronic devices (cochlea, drug infusion pump, nerve stimulator, etc.) or magnetic metal foreign bodies; possibility of requiring an MRI examination prior to capsule excretion
- Patients who cannot undergo surgery in the event of capsule retention
Show all 10Show fewer
- Pregnant and/or lactating women
- Patients with altered mental status (such as hepatic encephalopathy)
- Patients moribund from terminal malignant diseases or other end-stage illnesses with a limited life expectancy
- Unable to consent
About this study
Official title: Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding.
- Conditions
- Melena
- Being tested
- MCE first
- Keywords
- magnetically controlled capsule endoscopy, detection algorithm
- Medical subject headings
- Melena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCE firstDiagnostic test
Patients randomized to the "MCE first group" will have a MCE deployed as soon as possible once confirmed to fast for at least 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| MCE first group | Experimental | Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method. Receives: Diagnostic Test: MCE first |
| standard of care group | No intervention | For patients randomized to the Standard Care Group, gastroenterologists choose which procedures to perform and when to perform them based on their interpretation of the patient's presentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of bleeding lesions detection.
Detection rate of bleeding lesions is defined as proportion of patients in whom a potential bleeding lesion is identified. Visualization of gross blood (fresh/coffee grounds) without any lesion will not be considered as a positive diagnosis. The panel will provide a diagnosis based upon the lesion presenting the highest potential for bleeding if there are many lesions detected.
Measured: 1 month
Secondary outcomes (10)
The time of the bleeding lesions detected from admission
Measured: 1 month
The number of procedures patients underwent for detection of the bleeding lesions
Measured: 1 month
The number of colonoscopy needed
Measured: 1 month
Rate of therapeutic intervention required of all patients
Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.
Measured: 1 month
The length of hospital stay
Measured: 1 month
The cumulative direct cost of hospitalization
Measured: 1 month
Time to therapeutic intervention from presentation
Measured: 1 month
The rate of recurrent bleeding within 30 days of discharge
Further bleeding is defined as overt (hematemesis, melena or hematochezia) or occult (anemia or fecal occult blood positive) bleeding requiring subsequent hospitalization or transfusion, and/or signs of hypovolemic shock (systolic blood pressure of <100 mmHg and pulse rate >100 per min) or a drop-in hemoglobin level of >2g/dL per 24hours.
Measured: 1 month
The all-cause mortality within 30 days of discharge
Measured: 1 month
Transfusion rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Dec 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: few patients met all the inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelenaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019067
- Sponsor's protocol ID
- MCE-melena-2019
- Acronym
- FIRM
- Status last verified
- Sep 2020
- First submitted
- 12 Jul 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04019067
- Acronym / sponsor ID
- FIRM / MCE-melena-2019
- Conditions
- Melena
- Keywords
- magnetically controlled capsule endoscopy, detection algorithm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: few patients met all the inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Jul 2019 (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.
MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCE first group | Experimental | Diagnostic Test: MCE firstPatients randomized to the "MCE first group" will have a MCE deployed as the first detection method. |
| standard of care group | No intervention | –For patients randomized to the Standard Care Group, gastroenterologists choose which procedures to perform and when to perform them based on their interpretation of the patient's presentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Presenting to the outpatient department or emergency department with melena (without hematemesis) within the previous 48 hours
- Hemodynamically stable (blood pressure > 100/60 mmHg and heart rate < 100 bpm) at presentation
- No endoscopy performed after the new onset of melena
Key exclusion criteria (10 listed)
- Presenting with hematochezia and/or hematemesis within the previous 48 hours of presentation
- Hemodynamically stable after initial volume resuscitation
- Drop of hemoglobin level ≥ 2 g/dL/day, and/or need of transfusion ≥ 2 units of packed red blood cells per day
- Contraindications of CE (e.g. dysphagia, Zenker's diverticulum, esophageal stricture, known or suspected gastric or small bowel obstruction or perforation, gastroparesis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation, etc.)
- Presence of internal cardiac defibrillator (ICD), pacemaker and/or other implanted electronic devices (cochlea, drug infusion pump, nerve stimulator, etc.) or magnetic metal foreign bodies; possibility of requiring an MRI examination prior to capsule excretion
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 |
|---|---|---|
| MCE firstPatients randomized to the "MCE first group" will have a MCE deployed as soon as possible once confirmed to fast for at least 8 hours. | Diagnostic test | MCE first group |
Primary outcome
The rate of bleeding lesions detection.
Time frame: 1 month
Detection rate of bleeding lesions is defined as proportion of patients in whom a potential bleeding lesion is identified. Visualization of gross blood (fresh/coffee grounds) without any lesion will not be considered as a positive diagnosis. The panel will provide a diagnosis based upon the lesion presenting the highest potential for bleeding if there are many lesions detected.
10 secondary outcomes
The time of the bleeding lesions detected from admission
Time frame: 1 month
The number of procedures patients underwent for detection of the bleeding lesions
Time frame: 1 month
The number of colonoscopy needed
Time frame: 1 month
Rate of therapeutic intervention required of all patients
Time frame: 1 month
The length of hospital stay
Time frame: 1 month
The cumulative direct cost of hospitalization
Time frame: 1 month
Time to therapeutic intervention from presentation
Time frame: 1 month
The rate of recurrent bleeding within 30 days of discharge
Time frame: 1 month
The all-cause mortality within 30 days of discharge
Time frame: 1 month
Transfusion rate
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MCE first in people with Melena, run by Changhai Hospital.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 rate of bleeding lesions detection. (time frame: 1 month). 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 29 Sep 2020.