Lesion; DuodenumNCT04629768
Purastat Prevention Delayed Bleeding Duodenum
A study testing PuraStat in people with Lesion; Duodenum, run by Prof. Dr. Raf Bisschops at 1 site in Belgium.
Trial summary
PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesion; Duodenum
- What is being tested?
- PuraStat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Oct 2020to Sep 2023
- 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
- Duodenal non-ampullary mucosal lesion ≥ 10 mm
- ≥ 18y of age
- Informed consent obtained
Who cannot join
- Ampulloma
- Submucosal lesion
- Lesion < 10 mm
- >1 lesion resected
- Active use of anticoagulant or antithrombotic medication other than aspirin
- Known clotting disorder
- Inability to give informed consent
- < 18y of age
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Raf Bisschops, MD PhD, +3216342161, raf.bisschops@uzleuven.be
Ingrid Demedts, MD PhD, +3216345518, ingrid.demedts@uzleuven.be
About this study
Official title: A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.
- Conditions
- Lesion; Duodenum
- Being tested
- PuraStat
- Keywords
- Purastat, EMR duodenum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraStatDevice
Purastat is applied to the EMR defect
| Study group | Role | What they receive |
|---|---|---|
| Duodenal EMR + PuraStat | Other | PuraStat will be applied to the defect after duodenal EMR of the lesion Receives: Device: PuraStat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of active bleeding or high risk stigma of bleeding
On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed
Measured: 1 day after EMR
Secondary outcomes (5)
The presence of clinical signs of delayed bleeding
The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.
Measured: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of other adverse events
The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application
Measured: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The feasibility of PuraStat application: Amount
The amount of PuraStat will be investigated: Volume in mL
Measured: During EMR procedure
The feasibility of PuraStat application: Ease
The ease of application will be investigated: Questionnaire will be answered by the endoscopist.
Measured: During EMR procedure
The feasibility of Purastat application: Coverage
Is PuraStat covering the resection defect the day after the EMR? This will be investigated by questionnaire that will be answered by the endoscopist who performs the EGD
Measured: During EGD procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start2 Oct 2020
- Primary completionOct 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesion; DuodenumStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Raf Bisschops
- Sponsor type
- University, hospital or other
- Collaborators
- 3-D Matrix Europe SAS
- Responsible party
- Sponsor-investigator, Prof. Dr. Raf Bisschops, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Ingrid Demedts, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629768
- Sponsor's protocol ID
- S63851
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
- ClinicalTrials.gov ID
- NCT04629768
- Acronym / sponsor ID
- S63851
- Conditions
- Lesion; Duodenum
- Keywords
- Purastat, EMR duodenum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Prof. Dr. Raf BisschopsUniversity, hospital or other
- Collaborators
- 3-D Matrix Europe SAS
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 16 Nov 2020 (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.
PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duodenal EMR + PuraStat | Other | Device: PuraStatPuraStat will be applied to the defect after duodenal EMR of the lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duodenal non-ampullary mucosal lesion ≥ 10 mm
- ≥ 18y of age
- Informed consent obtained
Key exclusion criteria (8 listed)
- Ampulloma
- Submucosal lesion
- Lesion < 10 mm
- >1 lesion resected
- Active use of anticoagulant or antithrombotic medication other than aspirin
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 |
|---|---|---|
| PuraStatPurastat is applied to the EMR defect | Device | Duodenal EMR + PuraStat |
Primary outcome
The presence of active bleeding or high risk stigma of bleeding
Time frame: 1 day after EMR
On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed
5 secondary outcomes
The presence of clinical signs of delayed bleeding
Time frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of other adverse events
Time frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The feasibility of PuraStat application: Amount
Time frame: During EMR procedure
The feasibility of PuraStat application: Ease
Time frame: During EMR procedure
The feasibility of Purastat application: Coverage
Time frame: During EGD procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
Related trials for Lesion; Duodenum
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Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
Esophagogastroduodenoscopy, Simethicone
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.
Ingrid Demedts principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PuraStat in people with Lesion; Duodenum, run by Prof. Dr. Raf Bisschops at 1 site in Belgium.
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 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raf Bisschops (+3216342161, raf.bisschops@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of active bleeding or high risk stigma of bleeding (time frame: 1 day after EMR). 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 16 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.