Gastrointestinal BleedingPOPSNCT03983707
A Evaluation of the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
An observational study of Gastrointestinal Bleeding and Delayed Bleeding, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Problem statement GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Bleeding, Delayed Bleeding
- What is being tested?
- Purastat®
- Type of treatment
- Medical device
- How many people
- 379 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2019to 31 Oct 2021
- How long will I take part?
- 28 Days
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® is used
Who may be able to join
- Active GI bleeding or high risk for active GI bleeding
Who cannot join
- Variceal or arterial bleeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Read more
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
Read the detailed description
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
- Conditions
- Gastrointestinal Bleeding, Delayed Bleeding
- Being tested
- Purastat®
- Keywords
- Purastat
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purastat®Device
Use of Purastat®
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Purastat® in controlling bleeding
Number (and proportion) of bleeds successfully controlled by application of Purastat®
Measured: Day 1 (intraprocedural bleeding)
Effectiveness of Purastat® in controlling bleeding
Number (and proportion) of bleeds successfully controlled by application of Purastat®
Measured: Day 28 (delayed bleeding)
Secondary outcomes (4)
Effectiveness of Purastat® in preventing delayed bleeding
Delayed bleeding rate
Measured: Day 28
Technical feasibility of use of Purastat®
Any difficulty in Purastat application (yes/no)
Measured: Day 1 (periprocedural)
Unexpected reactions that may be attributed to the use of Purastat®
Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to Purastat®
Measured: Day 28
Patterns of Purastat® usage
Purastat® utilisation (including indications)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start23 Jan 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- 3-D Matrix Europe SAS, Gloucestershire Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Mid and South Essex NHS Foundation Trust, East Kent Hospitals University NHS Foundation Trust, University College London Hospitals, North Tees and Hartlepool NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, King's College Hospital NHS Trust, Imperial College Healthcare NHS Trust, Heart of England NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Barts & The London NHS Trust, London North West Healthcare NHS Trust, Manchester University NHS Foundation Trust, Oxford University Hospitals NHS Trust, Glasgow Royal Infirmary, Guy's and St Thomas' NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983707
- Sponsor's protocol ID
- PHT/2018/39
- Acronym
- POPS
- Status last verified
- Sep 2022
- First submitted
- 23 Apr 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT03983707
- Acronym / sponsor ID
- POPS / PHT/2018/39
- Conditions
- Gastrointestinal Bleeding, Delayed Bleeding
- Keywords
- Purastat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- 3-D Matrix Europe SAS, Gloucestershire Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Mid and South Essex NHS Foundation Trust, East Kent Hospitals University NHS Foundation Trust, University College London Hospitals, North Tees and Hartlepool NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, King's College Hospital NHS Trust, Imperial College Healthcare NHS Trust, Heart of England NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Barts & The London NHS Trust, London North West Healthcare NHS Trust, Manchester University NHS Foundation Trust, Oxford University Hospitals NHS Trust, Glasgow Royal Infirmary, Guy's and St Thomas' NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 12 Jun 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.
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
Detailed description
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® is used
Key inclusion criteria (1 listed)
- Active GI bleeding or high risk for active GI bleeding
Key exclusion criteria (1 listed)
- Variceal or arterial bleeding
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 |
|---|---|---|
| Purastat®Use of Purastat® | Device | – |
Primary outcome
Effectiveness of Purastat® in controlling bleeding
Time frame: Day 1 (intraprocedural bleeding)
Number (and proportion) of bleeds successfully controlled by application of Purastat®
Effectiveness of Purastat® in controlling bleeding
Time frame: Day 28 (delayed bleeding)
Number (and proportion) of bleeds successfully controlled by application of Purastat®
4 secondary outcomes
Effectiveness of Purastat® in preventing delayed bleeding
Time frame: Day 28
Technical feasibility of use of Purastat®
Time frame: Day 1 (periprocedural)
Unexpected reactions that may be attributed to the use of Purastat®
Time frame: Day 28
Patterns of Purastat® usage
Time frame: 24 months
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 31 May 2025.
- 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.
Pradeep Bhandari principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding and Delayed Bleeding, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 31 May 2025. 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 United Kingdom. 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?
Effectiveness of Purastat® in controlling bleeding (time frame: Day 1 (intraprocedural bleeding)). 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 May 2025.