Variceal HemorrhageNCT01783899
Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
A study testing Hemospray in people with Variceal Hemorrhage, run by Theodor Bilharz Research Institute at 2 sites in 2 countries.
Trial summary
The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Variceal Hemorrhage
- What is being tested?
- Hemospray
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2013to Jun 2014
- 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
- 18 Years and older
- Bleeding Esophageal and / or Gastric varices
Who cannot join
- Patient is: < 18 years of age
- Unable to consent
- Contraindicated to undergo endoscopy,
- Already hospitalized for another illness
- Pregnant or lactating
- Patients with altered post-surgical anatomy of the stomach
- Previously placed intrahepatic portosystemic shunt
- Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.
- Conditions
- Variceal Hemorrhage
- Being tested
- Hemospray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemosprayDevice
Patients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission.
once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip.
Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed.
Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy.
Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure.
Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care
| Study group | Role | What they receive |
|---|---|---|
| Hemospray Group | Experimental | Hemospray device consists of a syringe containing the Hemospray powder (21 g per syringe), a delivery catheter that will be inserted into the working channel of the endoscope, and an introducer handle with a built-in carbon dioxide canister to propel the Hemospray powder out of the catheter.
In addition to Hemospray device any other required endoscopic accessories can be used during the procedure. Receives: Device: Hemospray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
Measured: 24 hours
Secondary outcomes (1)
Effectiveness
Information on efficacy will be obtained by measurements the proportion of patients with acute (procedural) hemostasis, and the rate of recurrent bleeding within 72 hours of treatment.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionJun 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 Variceal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Principal investigator, Mostafa Ibrahim, Theodor Bilharz Research Institute
- Investigators
- Mostafa Ibrahim, MD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783899
- Sponsor's protocol ID
- Hemospray Varices
- Status last verified
- Dec 2014
- First submitted
- 1 Feb 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ibrahim M, El-Mikkawy A, Mostafa I, Deviere J. Endoscopic treatment of acute variceal hemorrhage by using hemostatic powder TC-325: a prospective pilot study. Gastrointest Endosc. 2013 Nov;78(5):769-73. doi: 10.1016/j.gie.2013.07.037.
PubMed 24120338
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
- ClinicalTrials.gov ID
- NCT01783899
- Acronym / sponsor ID
- Hemospray Varices
- Conditions
- Variceal Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Feb 2013 (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.
The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemospray Group | Experimental | Device: HemosprayHemospray device consists of a syringe containing the Hemospray powder (21 g per syringe), a delivery catheter that will be inserted into the working channel of the endoscope, and an introducer handle with a built-in carbon dioxide canister to propel the Hemospray powder out of the catheter. In addition to Hemospray device any other required endoscopic accessories can be used during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 Years and older
- Bleeding Esophageal and / or Gastric varices
Key exclusion criteria (8 listed)
- Patient is: < 18 years of age
- Unable to consent
- Contraindicated to undergo endoscopy,
- Already hospitalized for another illness
- Pregnant or lactating
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 |
|---|---|---|
| HemosprayPatients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission. once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed. Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy. Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure. Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care | Device | Hemospray Group |
Primary outcome
Safety
Time frame: 24 hours
Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
1 secondary outcome
Effectiveness
Time frame: 24 hours
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 30 Dec 2014.
- Derived from this study: PubMed 24120338Ibrahim M, El-Mikkawy A, Mostafa I, Deviere J. Endoscopic treatment of acute variceal hemorrhage by using hemostatic powder TC-325: a prospective pilot study. Gastrointest Endosc. 2013 Nov;78(5):769-73. doi: 10.1016/j.gie.2013.07.037.
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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.
Mostafa Ibrahim, MD principal investigator
Université Libre de Bruxelles
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemospray in people with Variceal Hemorrhage, run by Theodor Bilharz Research Institute at 2 sites in 2 countries.
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 8 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Egypt. 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?
Safety (time frame: 24 hours). 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 NCT01783899, 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 30 Dec 2014.