- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349490
Seraseal for Endoscopic Hemostasis
A Multi-centre Proof of Concept Study to Assess Efficacy and Safety of a New Liquid Endoscopic Hemostatic Agent (Seraseal / Fastact ®) in Patients With Active Gastrointestinal Bleeding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, certified for intraoperative use in humans (CE No 0653), is topically applied to the bleeding site. The delivery device consisted of a 5ml syringe containing Seraseal plugged to standard delivery catheters, either ERCP catheters or dye spraying catheters (Boston Scientific, USA) that are inserted via the working channel of the endoscope. Once the bleeding is identified at endoscopy, the delivery catheter is inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Seraseal is then delivered in short spray bursts or direct shots (for 1-2 seconds) until hemostasis is confirmed. A maximum of 5ml of Seraseal is administered in each patient. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.
Two groups are formed for analysis of this proof of concept study:
In group A, Seraseal is applied as initial method for hemostasis. If successful, the bleeding site is then observed for 5 minutes. If bleeding remains active or recurs, the institutional standard of care for hemostasis is applied.
In group B, Seraseal is applied as rescue therapy after an initial failure of the institutional standard method. If Seraseal is successful, the bleeding site is then observed for 5 minutes. If the bleeding remains active or recurs after Seraseal, alternative methods of hemostasis will be applied.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- active gastrointestinal hemorrhage
Exclusion Criteria:
- no sign of active bleeding at endoscopy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A first line therapy
In group A, Seraseal is applied as initial method for hemostasis.
If successful, the bleeding site isthen observed for 5 minutes.
If bleeding remains active or recurs the institutional standard of care for hemostasis is applied.
|
Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter
|
Active Comparator: Group B rescue therapy
In group B, Seraseal is applied as rescue therapy after an initial failure of the institutional standard method.
If Seraseal was successful, the bleeding site was then observed for 5 minutes.
If the bleeding remains active or recurs after Seraseal, alternative methods of hemostasis would be applied.
|
Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemostasis
Time Frame: 5min
|
Success (=Hemostasis) for 5 minutes after Seraseal application
|
5min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnulf Ferlitsch, MD, Medical University of Vienna
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Seraseal1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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