Gastrointestinal HemorrhageNCT02820077
Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
A study testing Hemospray (Endoscopic treatment with hemostatic powder) in people with Gastrointestinal Hemorrhage and Gastrointestinal Neoplasms, run by Instituto do Cancer do Estado de São Paulo.
Trial summary
This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms
- What is being tested?
- Hemospray (Endoscopic treatment with hemostatic powder)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2016to 27 Aug 2020
- 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
- Any kind of malignancy
- Gastrointestinal bleeding in the last 48 hours
- Referred to emergency endoscopy
Who cannot join
- under 18 years old
- bleeding from non malignant lesions
- previous endoscopic treatment with another method done in the last 48h
About this study
Official title: Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.
Read the detailed description
Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.
Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.
- Being tested
- Hemospray (Endoscopic treatment with hemostatic powder)
- Keywords
- Endoscopy, Gastrointestinal
- Medical subject headings
- Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemospray (Endoscopic treatment with hemostatic powder)Device
Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards
| Study group | Role | What they receive |
|---|---|---|
| Hemospray | Experimental | Patients treated with hemostatic powder Receives: Device: Hemospray (Endoscopic treatment with hemostatic powder) |
| Clinical support | No intervention | Patients treated with optimal clinical management, as it is been advised by the latest guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding
Measured: until 30 days after endoscopy
mortality
Measured: until 30 days after endoscopy
Secondary outcomes (2)
Successful initial hemostasis
Measured: From the moment of the procedure until 24 hours after it
Hospital length of stay
Measured: from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start6 Aug 2016
- Primary completion24 Jan 2020
- Study completion27 Aug 2020
Why it stopped: Global recall of Hemospray
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820077
- Sponsor's protocol ID
- NP883/15
- Status last verified
- Aug 2020
- First submitted
- 7 Jun 2016
- Last updated
- 31 Aug 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
- ClinicalTrials.gov ID
- NCT02820077
- Acronym / sponsor ID
- NP883/15
- Keywords
- Endoscopy, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Global recall of Hemospray
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 6 Aug 2016 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 30 Jun 2016 (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.
This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.
Detailed description
Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.
Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemospray | Experimental | Device: Hemospray (Endoscopic treatment with hemostatic powder)Patients treated with hemostatic powder |
| Clinical support | No intervention | –Patients treated with optimal clinical management, as it is been advised by the latest guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any kind of malignancy
- Gastrointestinal bleeding in the last 48 hours
- Referred to emergency endoscopy
Key exclusion criteria (3 listed)
- under 18 years old
- bleeding from non malignant lesions
- previous endoscopic treatment with another method done in the last 48h
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 |
|---|---|---|
| Hemospray (Endoscopic treatment with hemostatic powder)Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards | Device | Hemospray |
Primary outcome
rebleeding
Time frame: until 30 days after endoscopy
mortality
Time frame: until 30 days after endoscopy
2 secondary outcomes
Successful initial hemostasis
Time frame: From the moment of the procedure until 24 hours after it
Hospital length of stay
Time frame: from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months
Results and safety
The study was stopped early (reason given: Global recall of Hemospray). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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 Hemospray (Endoscopic treatment with hemostatic powder) in people with Gastrointestinal Hemorrhage and Gastrointestinal Neoplasms, run by Instituto do Cancer do Estado de São Paulo.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Aug 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 stopped early (reason given: Global recall of Hemospray). Results are not available in the source record.
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?
rebleeding (time frame: until 30 days after endoscopy). The study lists 2 primary outcomes in all. 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 31 Aug 2020.